Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT00602641
Collaborator
(none)
306
393
2
0.8

Study Details

Study Description

Brief Summary

This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. To compare progression-free survival between patients receiving melphalan, prednisone, and thalidomide versus melphalan, prednisone, and lenalidomide in newly diagnosed multiple myeloma patients who are not candidates for high-dose therapy.
SECONDARY OBJECTIVES:
  1. To compare overall survival between the arms. II. To compare response rates and depth of response. III. To compare the incidence of toxicities. IV. To validate the translocation classification (TC) of myeloma as a prognostic tool using gene expression profiling at diagnosis.
TERTIARY OBJECTIVES:
  1. To compare quality-of-life (QOL) change between arms based on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) Trial Outcome Index (TOI) from registration (prior to initiation of treatment) to the end of cycle 24 (maintenance therapy).

  2. To examine the impact of differential treatment response (PFS), if observed, on QOL based on the FACT-Ntx TOI up to cycle 38 (maintenance therapy).

  3. To obtain prospective data on myeloma specific QOL attributes.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I:

INDUCTION THERAPY: Patients receive melphalan orally (PO) and prednisone PO once daily (QD) on days 1-4, and thalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive thalidomide PO QD and continue in the absence of disease progression.

ARM II:

INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression.

After completion of study treatment, patients are followed up periodically for 10 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
306 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(TM))(MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy
Actual Study Start Date :
Feb 29, 2008
Actual Primary Completion Date :
Jan 18, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (thalidomide)

INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and thalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO QD and continue in the absence of disease progression.

Other: Laboratory Biomarker Analysis
Optional correlative studies

Drug: Melphalan
Given PO
Other Names:
  • Alanine Nitrogen Mustard
  • CB-3025
  • L-PAM
  • L-Phenylalanine Mustard
  • L-Sarcolysin
  • L-Sarcolysin Phenylalanine mustard
  • L-Sarcolysine
  • Melphalanum
  • Phenylalanine Mustard
  • Phenylalanine Nitrogen Mustard
  • Sarcoclorin
  • Sarkolysin
  • WR-19813
  • Drug: Prednisone
    Given PO
    Other Names:
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltasone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Orasone
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Drug: Thalidomide
    Given PO
    Other Names:
  • (+)-Thalidomide
  • (-)-Thalidomide
  • .alpha.-Phthalimidoglutarimide
  • 2, 6-Dioxo-3-phthalimidopiperidine
  • Alpha-Phthalimidoglutarimide
  • Contergan
  • Distaval
  • Kevadon
  • N-(2,6-Dioxo-3-piperidyl)phthalimide
  • N-Phthaloylglutamimide
  • N-Phthalylglutamic Acid Imide
  • Neurosedyn
  • Pantosediv
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (+)-
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (-)-
  • Sedalis
  • Sedoval K-17
  • Softenon
  • Synovir
  • Talimol
  • Thalomid
  • Experimental: Arm II (lenalidomide)

    INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression.

    Other: Laboratory Biomarker Analysis
    Optional correlative studies

    Drug: Lenalidomide
    Given PO
    Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
  • Drug: Melphalan
    Given PO
    Other Names:
  • Alanine Nitrogen Mustard
  • CB-3025
  • L-PAM
  • L-Phenylalanine Mustard
  • L-Sarcolysin
  • L-Sarcolysin Phenylalanine mustard
  • L-Sarcolysine
  • Melphalanum
  • Phenylalanine Mustard
  • Phenylalanine Nitrogen Mustard
  • Sarcoclorin
  • Sarkolysin
  • WR-19813
  • Drug: Prednisone
    Given PO
    Other Names:
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltasone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Orasone
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone
  • Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) [Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.]

      PFS is defined as the time from randomization to the earlier of progression or death of any cause.

    Secondary Outcome Measures

    1. Overall Survival [Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.]

      Overall survival was defined as time from randomization to death from any cause.

    2. Very Good Partial Response (VGPR) Rate [Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.]

      Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria.

    3. Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12 [Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.]

      A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients must have a confirmed diagnosis of symptomatic myeloma; for the original diagnosis of myeloma patients should have met the following criteria at one point in their disease course:

    • Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma

    • Patient must have had symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis namely; at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction

    • NOTE: Patients with asymptomatic smoldering myeloma (serum m protein >= 3 gm/dL or bone marrow plasma cells >= 10% or greater plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) and monoclonal gammopathy of undetermined significance (serum m protein < 3 gm/dL and bone marrow plasma cells < 10% plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) are not eligible

    • Patients must be > 65 and have declined alternative treatment OR patients who are >= 18 < 65 are eligible if they:

    • Are not a candidate for autologous stem cell transplantation in the opinion of the treating physician OR

    • Have declined transplant or other alternative treatment

    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2

    • All tests below must be performed within 28 days prior to randomization:

    • Serum free light chain assay

    • Kappa free light chain

    • Lambda free light chain

    • NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine; measurable disease in the serum is defined as having a serum M-spike >= 1 g/dL; measurable disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr

    • NOTE: urine protein electrophoresis (UPEP) (on a 24 hour collection) is required, no substitute method is acceptable; urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hr; please note that if both serum and urine m-components are present, both must be followed in order to evaluate response

    • Hemoglobin > 7 g/dL

    • Platelet count > 75,000 cells/mm^3

    • Absolute neutrophil count > 1000 cells/mm^3

    • Creatinine < 2.5 mg/dL and creatinine clearance (measured or calculated) > 60 mL/min

    • Total bilirubin =< 1.5 mg/dL

    • Serum glutamate pyruvate transaminase (SGPT) [alanine aminotransferase (ALT)] and serum glutamic oxaloacetic transaminase (SGOT) [aspartate aminotransferase (AST)] =< 2.5 times the upper limit of normal

    • Patients must be previously untreated for myeloma, although prior treatment for myeloma with prednisone or dexamethasone for less than 4 weeks total dosing alone or in combination with thalidomide or lenalidomide for less than 2 weeks total dosing is allowable

    • Patients may be receiving bisphosphonates or growth factors (erythropoietin) for multiple myeloma; although erythropoietin is allowed, it is strongly discouraged due to increased risk of thrombosis when employed alongside thalidomide and/or lenalidomide therapy

    • Patients must be willing and able to take prophylaxis with either aspirin at 325 mg/day or alternative prophylaxis with either low molecular weight heparin or Coumadin

    • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure

    • Patients must not have uncontrolled inter-current illness that would limit compliance with the study including:

    • Uncontrolled hypertension

    • Symptomatic congestive heart failure

    • Unstable angina

    • Uncontrolled cardiac arrhythmia

    • Uncontrolled psychiatric illness or social situation

    • Prior history of Stevens Johnson syndrome

    • Patients must not have grade 2 or higher peripheral neuropathy

    • Patients must not have an active, uncontrolled infection

    • Female patients MUST NOT be pregnant or breastfeeding; the use of these drugs in this patient population is ABSOLUTELY CONTRAINDICATED; for women of childbearing potential, a negative serum pregnancy test is required within 10-14 days prior to randomization; for female patients of childbearing potential a negative serum pregnancy test must be repeated within 24 hours prior to initiation of treatment, weekly for the first 4 weeks of treatment and then every 4 weeks if the patient's periods are regular or every 2 weeks if they are not; women of childbearing potential must be willing to refrain from sexual intercourse or must be willing to employ a dual method of contraception, one of which is highly effective [intrauterine device (IUD), birth control pills, tubal ligation or partner's vasectomy] and another additional method (condom, diaphragm or cervical cap) starting 4 weeks prior to and while taking lenalidomide and thalidomide and for four weeks after discontinuing this therapy; the male partner of a female using a single form of birth control should use a condom regardless of his vasectomy status

    • Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking lenalidomide and thalidomide and for 4 weeks after stopping treatment

    • Patients must not have had a second active malignancy requiring treatment within the last 2 years, with the exceptions of basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence Hospital Mobile Alabama United States 36608
    2 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
    3 Sparks Regional Medical Center Fort Smith Arkansas United States 72901
    4 UC San Diego Moores Cancer Center La Jolla California United States 92093
    5 Fremont - Rideout Cancer Center Marysville California United States 95901
    6 Memorial Medical Center Modesto California United States 95355
    7 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    8 UC San Diego Medical Center - Hillcrest San Diego California United States 92103
    9 Kaiser Permanente-San Diego Mission San Diego California United States 92108
    10 San Diego VA Medical Center San Diego California United States 92161
    11 Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California United States 96161
    12 The Medical Center of Aurora Aurora Colorado United States 80012
    13 Boulder Community Hospital Boulder Colorado United States 80301
    14 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    15 Porter Adventist Hospital Denver Colorado United States 80210
    16 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    17 SCL Health Saint Joseph Hospital Denver Colorado United States 80218
    18 Rose Medical Center Denver Colorado United States 80220
    19 Western States Cancer Research NCORP Denver Colorado United States 80222
    20 Swedish Medical Center Englewood Colorado United States 80113
    21 Poudre Valley Hospital Fort Collins Colorado United States 80524
    22 Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado United States 81501
    23 North Colorado Medical Center Greeley Colorado United States 80631
    24 Saint Anthony Hospital Lakewood Colorado United States 80228
    25 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    26 Longmont United Hospital Longmont Colorado United States 80501
    27 McKee Medical Center Loveland Colorado United States 80539
    28 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    29 North Suburban Medical Center Thornton Colorado United States 80229
    30 SCL Health Lutheran Medical Center Wheat Ridge Colorado United States 80033
    31 Hartford Hospital Hartford Connecticut United States 06102
    32 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    33 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    34 Broward Health Medical Center Fort Lauderdale Florida United States 33316
    35 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    36 Jupiter Medical Center Jupiter Florida United States 33458
    37 Mount Sinai Medical Center Miami Beach Florida United States 33140
    38 Phoebe Putney Memorial Hospital Albany Georgia United States 31701
    39 Piedmont Hospital Atlanta Georgia United States 30309
    40 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    41 Atlanta Regional CCOP Atlanta Georgia United States 30342
    42 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    43 Northside Hospital Atlanta Georgia United States 30342
    44 Augusta University Medical Center Augusta Georgia United States 30912
    45 WellStar Cobb Hospital Austell Georgia United States 30106
    46 John B Amos Cancer Center Columbus Georgia United States 31904
    47 Dekalb Medical Center Decatur Georgia United States 30033
    48 Dublin Hematology Oncology Care PC Dublin Georgia United States 31021
    49 Piedmont Fayette Hospital Fayetteville Georgia United States 30214
    50 Northside Hospital - Gwinnett Lawrenceville Georgia United States 30046
    51 Wellstar Kennestone Hospital Marietta Georgia United States 30060
    52 Southern Regional Medical Center Riverdale Georgia United States 30274
    53 Harbin Clinic Medical Oncology and Clinical Research Rome Georgia United States 30165
    54 Saint Anthony's Health Alton Illinois United States 62002
    55 Rush - Copley Medical Center Aurora Illinois United States 60504
    56 Saint Joseph Medical Center Bloomington Illinois United States 61701
    57 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    58 Graham Hospital Association Canton Illinois United States 61520
    59 Illinois CancerCare-Canton Canton Illinois United States 61520
    60 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    61 Memorial Hospital Carthage Illinois United States 62321
    62 Mount Sinai Hospital Medical Center Chicago Illinois United States 60608
    63 University of Illinois Chicago Illinois United States 60612
    64 Swedish Covenant Hospital Chicago Illinois United States 60625
    65 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    66 Heartland Cancer Research NCORP Decatur Illinois United States 62526
    67 Eureka Hospital Eureka Illinois United States 61530
    68 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    69 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    70 Saint Francis Hospital Evanston Illinois United States 60202
    71 Galesburg Cottage Hospital Galesburg Illinois United States 61401
    72 Illinois CancerCare-Cottage Galesburg Illinois United States 61401
    73 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    74 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    75 Illinois CancerCare-Havana Havana Illinois United States 62644
    76 Mason District Hospital Havana Illinois United States 62644
    77 Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois United States 60521
    78 Hopedale Medical Complex - Hospital Hopedale Illinois United States 61747
    79 Duly Health and Care Joliet Joliet Illinois United States 60435
    80 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    81 Kewanee Hospital Kewanee Illinois United States 61443
    82 AMITA Health Adventist Medical Center La Grange Illinois United States 60525
    83 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    84 Mcdonough District Hospital Macomb Illinois United States 61455
    85 Garneau, Stewart C MD (UIA Investigator) Moline Illinois United States 61265
    86 Porubcin, Michael MD (UIA Investigator) Moline Illinois United States 61265
    87 Sharis, Christine M MD (UIA Investigator) Moline Illinois United States 61265
    88 Spector, David MD (UIA Investigator) Moline Illinois United States 61265
    89 Stoffel, Thomas J MD (UIA Investigator) Moline Illinois United States 61265
    90 Trinity Medical Center Moline Illinois United States 61265
    91 Holy Family Medical Center Monmouth Illinois United States 61462
    92 Illinois CancerCare-Monmouth Monmouth Illinois United States 61462
    93 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    94 Bromenn Regional Medical Center Normal Illinois United States 61761
    95 Carle Cancer Institute Normal Normal Illinois United States 61761
    96 Illinois CancerCare-Community Cancer Center Normal Illinois United States 61761
    97 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    98 Ottawa Regional Hospital and Healthcare Center Ottawa Illinois United States 61350
    99 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    100 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
    101 Pekin Hospital Pekin Illinois United States 61554
    102 Proctor Hospital Peoria Illinois United States 61614
    103 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    104 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    105 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    106 Illinois CancerCare-Peru Peru Illinois United States 61354
    107 Illinois Valley Hospital Peru Illinois United States 61354
    108 Valley Radiation Oncology Peru Illinois United States 61354
    109 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    110 Perry Memorial Hospital Princeton Illinois United States 61356
    111 Swedish American Hospital Rockford Illinois United States 61104
    112 Illinois CancerCare-Spring Valley Spring Valley Illinois United States 61362
    113 Saint Margaret's Hospital Spring Valley Illinois United States 61362
    114 Memorial Medical Center Springfield Illinois United States 62781
    115 Carle Cancer Center Urbana Illinois United States 61801
    116 Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana United States 46107
    117 IU Health Arnett Cancer Care Lafayette Indiana United States 47904
    118 Franciscan Saint Anthony Health-Michigan City Michigan City Indiana United States 46360
    119 The Community Hospital Munster Indiana United States 46321
    120 Reid Health Richmond Indiana United States 47374
    121 McFarland Clinic PC - Ames Ames Iowa United States 50010
    122 Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa United States 52722
    123 University of Iowa Healthcare Cancer Services Quad Cities Bettendorf Iowa United States 52722
    124 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    125 Genesis Medical Center - East Campus Davenport Iowa United States 52803
    126 Genesis Cancer Care Institute Davenport Iowa United States 52804
    127 Mercy Capitol Des Moines Iowa United States 50307
    128 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    129 Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa United States 50309
    130 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    131 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    132 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    133 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    134 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    135 Iowa City VA Healthcare System Iowa City Iowa United States 52246
    136 Mercy Medical Center - North Iowa Mason City Iowa United States 50401
    137 Ottumwa Regional Health Center Ottumwa Iowa United States 52501
    138 Siouxland Regional Cancer Center Sioux City Iowa United States 51101
    139 Mercy Medical Center-Sioux City Sioux City Iowa United States 51102
    140 Saint Luke's Regional Medical Center Sioux City Iowa United States 51104
    141 Cedar Valley Medical Specialists Waterloo Iowa United States 50701
    142 MercyOne Waterloo Medical Center Waterloo Iowa United States 50702
    143 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    144 Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas United States 66606
    145 Wesley Medical Center Wichita Kansas United States 67214
    146 Doctors Carrol, Sheth, Raghavan Louisville Kentucky United States 40215
    147 Owensboro Health Mitchell Memorial Cancer Center Owensboro Kentucky United States 42303
    148 Ochsner Health Center-Summa Baton Rouge Louisiana United States 70809
    149 Ochsner Health Center-Covington Covington Louisiana United States 70433
    150 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    151 Mercy Hospital Portland Maine United States 04101
    152 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    153 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
    154 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    155 Addison Gilbert Hospital Gloucester Massachusetts United States 01930
    156 Michigan Cancer Research Consortium NCORP Ann Arbor Michigan United States 48106
    157 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    158 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    159 Ascension Saint John Hospital Detroit Michigan United States 48236
    160 Hurley Medical Center Flint Michigan United States 48503
    161 Genesys Regional Medical Center-West Flint Campus Flint Michigan United States 48532
    162 Allegiance Health Jackson Michigan United States 49201
    163 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    164 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    165 Borgess Medical Center Kalamazoo Michigan United States 49048
    166 Sparrow Hospital Lansing Michigan United States 48912
    167 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    168 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    169 Lake Huron Medical Center Port Huron Michigan United States 48060
    170 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    171 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    172 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    173 Essentia Health Saint Joseph's Medical Center Brainerd Minnesota United States 56401
    174 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    175 Mercy Hospital Coon Rapids Minnesota United States 55433
    176 Essentia Health Cancer Center Duluth Minnesota United States 55805
    177 Essentia Health Saint Mary's Medical Center Duluth Minnesota United States 55805
    178 Miller-Dwan Hospital Duluth Minnesota United States 55805
    179 Fairview Southdale Hospital Edina Minnesota United States 55435
    180 Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota United States 56537
    181 Unity Hospital Fridley Minnesota United States 55432
    182 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
    183 Meeker County Memorial Hospital Litchfield Minnesota United States 55355
    184 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    185 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    186 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    187 Virginia Piper Cancer Institute Minneapolis Minnesota United States 55407
    188 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    189 Minneapolis VA Medical Center Minneapolis Minnesota United States 55417
    190 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    191 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    192 Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota United States 55416
    193 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    194 Regions Hospital Saint Paul Minnesota United States 55101
    195 Saint Joseph's Hospital - Healtheast Saint Paul Minnesota United States 55102
    196 United Hospital Saint Paul Minnesota United States 55102
    197 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    198 Lakeview Hospital Stillwater Minnesota United States 55082
    199 Ridgeview Medical Center Waconia Minnesota United States 55387
    200 Rice Memorial Hospital Willmar Minnesota United States 56201
    201 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    202 Woodwinds Health Campus Woodbury Minnesota United States 55125
    203 Singing River Hospital Pascagoula Mississippi United States 39581
    204 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    205 Cox Cancer Center Branson Branson Missouri United States 65616
    206 Southeast Missouri Hospital Cape Girardeau Missouri United States 63701
    207 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    208 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    209 Saint Luke's Hospital Chesterfield Missouri United States 63017
    210 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    211 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    212 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    213 Center for Cancer Care and Research Saint Louis Missouri United States 63141
    214 Comprehensive Cancer Care PC Saint Louis Missouri United States 63141
    215 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    216 Saint Louis-Cape Girardeau CCOP Saint Louis Missouri United States 63141
    217 Cancer Research for the Ozarks NCORP Springfield Missouri United States 65804
    218 Mercy Hospital Springfield Springfield Missouri United States 65804
    219 CoxHealth South Hospital Springfield Missouri United States 65807
    220 Billings Clinic Cancer Center Billings Montana United States 59101
    221 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
    222 Saint Vincent Healthcare Billings Montana United States 59101
    223 Montana Cancer Consortium NCORP Billings Montana United States 59102
    224 Saint Vincent Frontier Cancer Center Billings Montana United States 59102
    225 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    226 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    227 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    228 Berdeaux, Donald MD (UIA Investigator) Great Falls Montana United States 59405
    229 Great Falls Clinic Great Falls Montana United States 59405
    230 Northern Montana Hospital Havre Montana United States 59501
    231 Saint Peter's Community Hospital Helena Montana United States 59601
    232 Glacier Oncology PLLC Kalispell Montana United States 59901
    233 Kalispell Medical Oncology Kalispell Montana United States 59901
    234 Kalispell Regional Medical Center Kalispell Montana United States 59901
    235 Montana Cancer Specialists Missoula Montana United States 59802
    236 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    237 Community Medical Hospital Missoula Montana United States 59804
    238 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
    239 CHI Health Good Samaritan Kearney Nebraska United States 68847
    240 Nebraska Cancer Research Center Lincoln Nebraska United States 68510
    241 Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    242 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    243 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    244 Creighton University Medical Center Omaha Nebraska United States 68131
    245 University of Nebraska Medical Center Omaha Nebraska United States 68198
    246 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    247 Nevada Cancer Institute-Summerlin Campus Las Vegas Nevada United States 89135
    248 Nevada Cancer Research Foundation NCORP Las Vegas Nevada United States 89169
    249 Veterans Adminstration New Jersey Health Care System East Orange New Jersey United States 07018-1095
    250 Virtua Memorial Mount Holly New Jersey United States 08060
    251 Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
    252 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    253 Rutgers New Jersey Medical School Newark New Jersey United States 07101
    254 Virtua Voorhees Voorhees New Jersey United States 08043
    255 Montefiore Medical Center-Wakefield Campus Bronx New York United States 10466
    256 Kings County Hospital Brooklyn New York United States 11203
    257 State University of New York Downstate Medical Center Brooklyn New York United States 11203
    258 Roswell Park Cancer Institute Buffalo New York United States 14263
    259 Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York United States 13057
    260 Veterans Affairs New York Harbor Healthcare System-Manhattan Campus New York New York United States 10010
    261 University of Rochester Rochester New York United States 14642
    262 Stony Brook University Medical Center Stony Brook New York United States 11794
    263 Syracuse Veterans Administration Medical Center Syracuse New York United States 13210
    264 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    265 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    266 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    267 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    268 Vidant Oncology-Kinston Kinston North Carolina United States 28501
    269 UNC Rex Cancer Center Raleigh North Carolina United States 27607
    270 Mid Dakota Clinic Bismarck North Dakota United States 58501
    271 Saint Alexius Medical Center Bismarck North Dakota United States 58501
    272 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    273 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    274 Sanford Clinic North-Fargo Fargo North Dakota United States 58122
    275 Summa Health System - Akron Campus Akron Ohio United States 44304
    276 Summa Health System - Barberton Campus Barberton Ohio United States 44203
    277 Mary Rutan Hospital Bellefontaine Ohio United States 43311
    278 Cleveland Clinic Mercy Hospital Canton Ohio United States 44708
    279 Aultman Health Foundation Canton Ohio United States 44710
    280 Adena Regional Medical Center Chillicothe Ohio United States 45601
    281 Case Western Reserve University Cleveland Ohio United States 44106
    282 MetroHealth Medical Center Cleveland Ohio United States 44109
    283 Riverside Methodist Hospital Columbus Ohio United States 43214
    284 Columbus NCI Community Oncology Research Program Columbus Ohio United States 43215
    285 Grant Medical Center Columbus Ohio United States 43215
    286 Mount Carmel Health Center West Columbus Ohio United States 43222
    287 Doctors Hospital Columbus Ohio United States 43228
    288 Grandview Hospital Dayton Ohio United States 45405
    289 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
    290 Miami Valley Hospital Dayton Ohio United States 45409
    291 Miami Valley Hospital North Dayton Ohio United States 45415
    292 Dayton Veterans Affairs Medical Center Dayton Ohio United States 45428
    293 Dayton NCI Community Oncology Research Program Dayton Ohio United States 45459
    294 Grady Memorial Hospital Delaware Ohio United States 43015
    295 Blanchard Valley Hospital Findlay Ohio United States 45840
    296 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    297 Wayne Hospital Greenville Ohio United States 45331
    298 Kettering Medical Center Kettering Ohio United States 45429
    299 Fairfield Medical Center Lancaster Ohio United States 43130
    300 Saint Rita's Medical Center Lima Ohio United States 45801
    301 Marietta Memorial Hospital Marietta Ohio United States 45750
    302 Knox Community Hospital Mount Vernon Ohio United States 43050
    303 Licking Memorial Hospital Newark Ohio United States 43055
    304 Springfield Regional Medical Center Springfield Ohio United States 45505
    305 Upper Valley Medical Center Troy Ohio United States 45373
    306 Saint Ann's Hospital Westerville Ohio United States 43081
    307 Clinton Memorial Hospital Wilmington Ohio United States 45177
    308 Greene Memorial Hospital Xenia Ohio United States 45385
    309 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    310 Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma United States 73505
    311 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    312 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    313 Providence Milwaukie Hospital Milwaukie Oregon United States 97222
    314 Providence Newberg Medical Center Newberg Oregon United States 97132
    315 Providence Willamette Falls Medical Center Oregon City Oregon United States 97045
    316 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    317 Providence Portland Medical Center Portland Oregon United States 97213
    318 Adventist Medical Center Portland Oregon United States 97216
    319 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    320 Compass Oncology Rose Quarter Portland Oregon United States 97227
    321 Legacy Emanuel Hospital and Health Center Portland Oregon United States 97227
    322 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
    323 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    324 Adams Cancer Center Gettysburg Pennsylvania United States 17325
    325 Cherry Tree Cancer Center Hanover Pennsylvania United States 17331
    326 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    327 Central PA Hematology-Medical Oncology Associates PC Lemoyne Pennsylvania United States 17043
    328 Lewistown Hospital Lewistown Pennsylvania United States 17044
    329 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
    330 Einstein Medical Center Philadelphia Philadelphia Pennsylvania United States 19141
    331 Phoenixville Hospital Phoenixville Pennsylvania United States 19460
    332 Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania United States 18840
    333 Mount Nittany Medical Center State College Pennsylvania United States 16803
    334 UPMC Susquehanna Williamsport Pennsylvania United States 17701
    335 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    336 Main Line Health NCORP Wynnewood Pennsylvania United States 19096
    337 WellSpan Health-York Cancer Center York Pennsylvania United States 17403
    338 WellSpan Health-York Hospital York Pennsylvania United States 17403
    339 Rapid City Regional Hospital Rapid City South Dakota United States 57701
    340 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    341 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    342 Medical X-Ray Center Sioux Falls South Dakota United States 57105
    343 Avera McKennan Hospital and University Health Center Sioux Falls South Dakota United States 57117-5045
    344 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    345 Cookeville Regional Medical Center Cookeville Tennessee United States 38501
    346 Jackson-Madison County General Hospital Jackson Tennessee United States 38301
    347 The Jackson Clinic PA Jackson Tennessee United States 38301
    348 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    349 Scott and White Memorial Hospital Temple Texas United States 76508
    350 University of Virginia Cancer Center Charlottesville Virginia United States 22908
    351 Danville Regional Medical Center Danville Virginia United States 24541
    352 Sovah Health Martinsville Martinsville Virginia United States 24115
    353 MultiCare Auburn Medical Center Auburn Washington United States 98001
    354 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    355 Saint Francis Hospital Federal Way Washington United States 98003
    356 Saint Clare Hospital Lakewood Washington United States 98499
    357 Providence - Saint Peter Hospital Olympia Washington United States 98506-5166
    358 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    359 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    360 MultiCare Allenmore Hospital Tacoma Washington United States 98405
    361 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    362 Northwest NCI Community Oncology Research Program Tacoma Washington United States 98405
    363 Saint Joseph Medical Center Tacoma Washington United States 98405
    364 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    365 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    366 West Virginia University Charleston Division Charleston West Virginia United States 25304
    367 Camden Clark Medical Center Parkersburg West Virginia United States 26101
    368 Princeton Community Hospital Princeton West Virginia United States 24740
    369 ThedaCare Regional Cancer Center Appleton Wisconsin United States 54911
    370 HSHS Sacred Heart Hospital Eau Claire Wisconsin United States 54701
    371 Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin United States 54701
    372 Saint Agnes Hospital/Agnesian Cancer Center Fond Du Lac Wisconsin United States 54935
    373 UW Cancer Center Johnson Creek Johnson Creek Wisconsin United States 53038
    374 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    375 Dean Hematology and Oncology Clinic Madison Wisconsin United States 53717
    376 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    377 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    378 Marshfield Medical Center Marshfield Wisconsin United States 54449
    379 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    380 ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
    381 Ascension Saint Mary's Hospital Rhinelander Wisconsin United States 54501
    382 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    383 Ascension Saint Michael's Hospital Stevens Point Wisconsin United States 54481
    384 ProHealth Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    385 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    386 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
    387 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    388 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494
    389 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    390 Rocky Mountain Oncology Casper Wyoming United States 82609
    391 Welch Cancer Center Sheridan Wyoming United States 82801
    392 Rambam Medical Center Haifa Israel 31096
    393 Shaare Zedek Medical Center Jerusalem Israel 91031

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Alexander K Stewart, ECOG-ACRIN Cancer Research Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00602641
    Other Study ID Numbers:
    • NCI-2009-00522
    • NCI-2009-00522
    • ECOG-E1A06
    • CDR0000583984
    • E1A06
    • E1A06
    • E1A06
    • U10CA180820
    • U10CA021115
    First Posted:
    Jan 28, 2008
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022

    Study Results

    Participant Flow

    Recruitment Details The study was activated on February 29, 2008 and closed to accrual on November 30, 2011 with final accrual of 306 patients.
    Pre-assignment Detail
    Arm/Group Title Arm I (MPT-T) Arm II (mPR-R)
    Arm/Group Description Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan 9 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and thalidomide 100 mg PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide 100 mg PO daily and continue in the absence of disease progression. Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan 5 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and lenalidomide 10 mg PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide 10 mg PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
    Period Title: Overall Study
    STARTED 154 152
    Started Protocol Therapy 148 150
    COMPLETED 0 0
    NOT COMPLETED 154 152

    Baseline Characteristics

    Arm/Group Title Arm I (MPT-T) Arm II (mPR-R) Total
    Arm/Group Description Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression. melphalan: Given PO prednisone: Given PO thalidomide: Given PO Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression. melphalan: Given PO prednisone: Given PO lenalidomide: Given PO Total of all reporting groups
    Overall Participants 154 152 306
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    9
    5.8%
    6
    3.9%
    15
    4.9%
    >=65 years
    145
    94.2%
    146
    96.1%
    291
    95.1%
    Sex: Female, Male (Count of Participants)
    Female
    68
    44.2%
    71
    46.7%
    139
    45.4%
    Male
    86
    55.8%
    81
    53.3%
    167
    54.6%
    International Staging System (ISS) (participants) [Number]
    Stage I
    45
    29.2%
    36
    23.7%
    81
    26.5%
    Stage II
    58
    37.7%
    70
    46.1%
    128
    41.8%
    Stage III
    49
    31.8%
    46
    30.3%
    95
    31%
    Unknown/Missing
    2
    1.3%
    0
    0%
    2
    0.7%

    Outcome Measures

    1. Primary Outcome
    Title Progression-Free Survival (PFS)
    Description PFS is defined as the time from randomization to the earlier of progression or death of any cause.
    Time Frame Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treat (ITT) population
    Arm/Group Title Arm I (MPT-T) Arm II (mPR-R)
    Arm/Group Description Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression. Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
    Measure Participants 154 152
    Median (95% Confidence Interval) [months]
    21.0
    18.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (MPT-T), Arm II (mPR-R)
    Comments Since mPR-R was expected to be considerably less toxic and to confer slightly longer PFS, a non-inferiority design with superiority alternative was used.
    Type of Statistical Test Non-Inferiority or Equivalence (legacy)
    Comments Presuming the control over the experimental arm (MPT-T/mPR-R), the inferiority of mPR-R was defined as a PFS treatment hazard ratio (HR) of less than or equal to 0.82 corresponding to median PFS on the mPR-R arm of 20.5 months (mos) vs. 25 mos on the MPT-T arm. With 304 patients and 221 PFS events, there was 86% power to detect non-inferiority of mPR-R at a 1-sided 0.05 significance level assuming a superiority alternative of HR=1.2 corresponding to median PFS on the mPR-R arm of 30 mos.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.84
    Confidence Interval (2-Sided) 90%
    0.67 to 1.045
    Parameter Dispersion Type:
    Value:
    Estimation Comments Analysis based on stratified cox regression by ISS stage (I-II vs. III) and age (< 65y vs. ≥ 65y). The fact that the lower-bound was less than 0.82 and the upper bound was above 1.0 indicates that results were inconclusive for the primary objective.
    2. Secondary Outcome
    Title Overall Survival
    Description Overall survival was defined as time from randomization to death from any cause.
    Time Frame Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treatment (ITT) population
    Arm/Group Title Arm I (MPT-T) Arm II (mPR-R)
    Arm/Group Description Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression. Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
    Measure Participants 154 152
    Median (95% Confidence Interval) [months]
    52.6
    47.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (MPT-T), Arm II (mPR-R)
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.476
    Comments
    Method Log Rank
    Comments Analysis was based on stratified cox regression by ISS stage (I-II vs. III) and age (< 65y vs. ≥ 65y).
    3. Secondary Outcome
    Title Very Good Partial Response (VGPR) Rate
    Description Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria.
    Time Frame Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treat (ITT) population
    Arm/Group Title Arm I (MPT-T) Arm II (mPR-R)
    Arm/Group Description Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression. Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
    Measure Participants 154 152
    Number (95% Confidence Interval) [proportion of participants]
    0.247
    0.2%
    0.316
    0.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (MPT-T), Arm II (mPR-R)
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.204
    Comments
    Method Fisher Exact
    Comments
    4. Secondary Outcome
    Title Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12
    Description A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome).
    Time Frame Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.

    Outcome Measure Data

    Analysis Population Description
    Patients who completed both baseline and cycle 12 QOL assessments.
    Arm/Group Title Arm I (MPT-T) Arm II (mPR-R)
    Arm/Group Description Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression. Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
    Measure Participants 66 68
    Mean (Standard Deviation) [units on a scale]
    -2.8
    (15.0)
    3.3
    (13.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (MPT-T), Arm II (mPR-R)
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments

    Adverse Events

    Time Frame Assessed every 28 days while on treatment and for 30 days after the end of treatment
    Adverse Event Reporting Description
    Arm/Group Title MPT-T mPR-R
    Arm/Group Description Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression. Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
    All Cause Mortality
    MPT-T mPR-R
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    MPT-T mPR-R
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 110/148 (74.3%) 88/150 (58.7%)
    Blood and lymphatic system disorders
    Anemia 16/148 (10.8%) 11/150 (7.3%)
    Hemolysis 0/148 (0%) 1/150 (0.7%)
    Febrile neutropenia 3/148 (2%) 0/150 (0%)
    Cardiac disorders
    Asystole 1/148 (0.7%) 0/150 (0%)
    Atrial fibrillation 0/148 (0%) 2/150 (1.3%)
    Sinus bradycardia 2/148 (1.4%) 0/150 (0%)
    Myocardial infarction 3/148 (2%) 3/150 (2%)
    Heart failure 2/148 (1.4%) 0/150 (0%)
    Left ventricular systolic dysfunction 2/148 (1.4%) 0/150 (0%)
    Restrictive cardiomyopathy 0/148 (0%) 1/150 (0.7%)
    Cardiac disorders - Other, specify 1/148 (0.7%) 0/150 (0%)
    Chest pain - cardiac 1/148 (0.7%) 1/150 (0.7%)
    Eye disorders
    Cataract 1/148 (0.7%) 0/150 (0%)
    Gastrointestinal disorders
    Constipation 8/148 (5.4%) 0/150 (0%)
    Diarrhea 0/148 (0%) 3/150 (2%)
    Esophagitis 0/148 (0%) 1/150 (0.7%)
    Mucositis oral 0/148 (0%) 1/150 (0.7%)
    Nausea 4/148 (2.7%) 1/150 (0.7%)
    Intra-abdominal hemorrhage 1/148 (0.7%) 0/150 (0%)
    Duodenal hemorrhage 0/148 (0%) 1/150 (0.7%)
    Upper gastrointestinal hemorrhage 1/148 (0.7%) 0/150 (0%)
    Abdominal pain 1/148 (0.7%) 0/150 (0%)
    Oral pain 0/148 (0%) 1/150 (0.7%)
    General disorders
    Fatigue 16/148 (10.8%) 14/150 (9.3%)
    Fever 0/148 (0%) 1/150 (0.7%)
    Sudden death NOS 2/148 (1.4%) 0/150 (0%)
    Edema face 1/148 (0.7%) 0/150 (0%)
    Edema limbs 3/148 (2%) 1/150 (0.7%)
    Non-cardiac chest pain 0/148 (0%) 1/150 (0.7%)
    Immune system disorders
    Anaphylaxis 0/148 (0%) 1/150 (0.7%)
    Infections and infestations
    Enterocolitis infectious 1/148 (0.7%) 0/150 (0%)
    Infections and infestations - Other, spe 1/148 (0.7%) 0/150 (0%)
    Infections and infestations - Other, spe 5/148 (3.4%) 2/150 (1.3%)
    Infections and infestations - Other, spe 0/148 (0%) 1/150 (0.7%)
    Abdominal infection 0/148 (0%) 1/150 (0.7%)
    Bladder infection 0/148 (0%) 1/150 (0.7%)
    Tooth infection 0/148 (0%) 1/150 (0.7%)
    Joint infection 0/148 (0%) 3/150 (2%)
    Lung infection 4/148 (2.7%) 3/150 (2%)
    Skin infection 2/148 (1.4%) 2/150 (1.3%)
    Urinary tract infection 2/148 (1.4%) 1/150 (0.7%)
    Bronchial infection 0/148 (0%) 1/150 (0.7%)
    Skin infection 0/148 (0%) 1/150 (0.7%)
    Urinary tract infection 1/148 (0.7%) 0/150 (0%)
    Infections and infestations - Other, spe 1/148 (0.7%) 1/150 (0.7%)
    Infections and infestations - Other, spe 2/148 (1.4%) 3/150 (2%)
    Injury, poisoning and procedural complications
    Fracture 0/148 (0%) 1/150 (0.7%)
    Vascular access complication 0/148 (0%) 1/150 (0.7%)
    Investigations
    White blood cell decreased 29/148 (19.6%) 17/150 (11.3%)
    Lymphocyte count decreased 21/148 (14.2%) 10/150 (6.7%)
    Neutrophil count decreased 41/148 (27.7%) 43/150 (28.7%)
    Platelet count decreased 18/148 (12.2%) 14/150 (9.3%)
    Weight loss 0/148 (0%) 1/150 (0.7%)
    INR increased 0/148 (0%) 1/150 (0.7%)
    Aspartate aminotransferase increased 0/148 (0%) 1/150 (0.7%)
    Creatinine increased 2/148 (1.4%) 3/150 (2%)
    Metabolism and nutrition disorders
    Anorexia 0/148 (0%) 1/150 (0.7%)
    Dehydration 0/148 (0%) 3/150 (2%)
    Acidosis 0/148 (0%) 2/150 (1.3%)
    Hypocalcemia 0/148 (0%) 1/150 (0.7%)
    Hyperglycemia 3/148 (2%) 2/150 (1.3%)
    Hypophosphatemia 0/148 (0%) 1/150 (0.7%)
    Hyperkalemia 0/148 (0%) 1/150 (0.7%)
    Hypokalemia 2/148 (1.4%) 3/150 (2%)
    Hyponatremia 3/148 (2%) 2/150 (1.3%)
    Hyperuricemia 0/148 (0%) 1/150 (0.7%)
    Musculoskeletal and connective tissue disorders
    Muscle weakness upper limb 0/148 (0%) 1/150 (0.7%)
    Muscle weakness lower limb 1/148 (0.7%) 1/150 (0.7%)
    Musculoskeletal and connective tissue di 4/148 (2.7%) 2/150 (1.3%)
    Back pain 1/148 (0.7%) 0/150 (0%)
    Bone pain 1/148 (0.7%) 1/150 (0.7%)
    Chest wall pain 0/148 (0%) 1/150 (0.7%)
    Pain in extremity 0/148 (0%) 1/150 (0.7%)
    Myalgia 1/148 (0.7%) 0/150 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Myelodysplastic syndrome 1/148 (0.7%) 0/150 (0%)
    Treatment related secondary malignancy 2/148 (1.4%) 1/150 (0.7%)
    Nervous system disorders
    Nervous system disorders - Other, specif 5/148 (3.4%) 2/150 (1.3%)
    Cognitive disturbance 1/148 (0.7%) 0/150 (0%)
    Dizziness 1/148 (0.7%) 1/150 (0.7%)
    Cognitive disturbance 0/148 (0%) 1/150 (0.7%)
    Peripheral motor neuropathy 2/148 (1.4%) 0/150 (0%)
    Peripheral sensory neuropathy 6/148 (4.1%) 1/150 (0.7%)
    Seizure 1/148 (0.7%) 0/150 (0%)
    Depressed level of consciousness 1/148 (0.7%) 0/150 (0%)
    Dysphasia 1/148 (0.7%) 0/150 (0%)
    Syncope 3/148 (2%) 1/150 (0.7%)
    Tremor 4/148 (2.7%) 0/150 (0%)
    Nervous system disorders - Other, specif 1/148 (0.7%) 0/150 (0%)
    Headache 1/148 (0.7%) 1/150 (0.7%)
    Psychiatric disorders
    Confusion 1/148 (0.7%) 1/150 (0.7%)
    Anxiety 2/148 (1.4%) 0/150 (0%)
    Depression 4/148 (2.7%) 1/150 (0.7%)
    Renal and urinary disorders
    Chronic kidney disease 0/148 (0%) 1/150 (0.7%)
    Acute kidney injury 3/148 (2%) 1/150 (0.7%)
    Reproductive system and breast disorders
    Gynecomastia 1/148 (0.7%) 0/150 (0%)
    Respiratory, thoracic and mediastinal disorders
    Adult respiratory distress syndrome 1/148 (0.7%) 0/150 (0%)
    Bronchospasm 0/148 (0%) 1/150 (0.7%)
    Dyspnea 12/148 (8.1%) 6/150 (4%)
    Laryngeal edema 0/148 (0%) 1/150 (0.7%)
    Hypoxia 0/148 (0%) 1/150 (0.7%)
    Pneumonitis 1/148 (0.7%) 0/150 (0%)
    Respiratory, thoracic and mediastinal di 1/148 (0.7%) 0/150 (0%)
    Skin and subcutaneous tissue disorders
    Rash maculo-papular 3/148 (2%) 5/150 (3.3%)
    Palmar-plantar erythrodysesthesia syndro 1/148 (0.7%) 0/150 (0%)
    Vascular disorders
    Hypertension 1/148 (0.7%) 1/150 (0.7%)
    Hypotension 0/148 (0%) 2/150 (1.3%)
    Thromboembolic event 13/148 (8.8%) 9/150 (6%)
    Other (Not Including Serious) Adverse Events
    MPT-T mPR-R
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 29/148 (19.6%) 34/151 (22.5%)
    Blood and lymphatic system disorders
    Anemia 11/148 (7.4%) 22/151 (14.6%)
    Gastrointestinal disorders
    Constipation 10/148 (6.8%) 9/151 (6%)
    General disorders
    Fatigue 14/148 (9.5%) 15/151 (9.9%)
    Investigations
    White blood cell decreased 12/148 (8.1%) 17/151 (11.3%)
    Lymphocyte count decreased 10/148 (6.8%) 9/151 (6%)
    Neutrophil count decreased 8/148 (5.4%) 12/151 (7.9%)
    Platelet count decreased 10/148 (6.8%) 17/151 (11.3%)
    Nervous system disorders
    Peripheral sensory neuropathy 8/148 (5.4%) 2/151 (1.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Study Statistician
    Organization ECOG Statistical Office
    Phone 617-632-3012
    Email
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00602641
    Other Study ID Numbers:
    • NCI-2009-00522
    • NCI-2009-00522
    • ECOG-E1A06
    • CDR0000583984
    • E1A06
    • E1A06
    • E1A06
    • U10CA180820
    • U10CA021115
    First Posted:
    Jan 28, 2008
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022