Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
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:
- 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:
- 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:
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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).
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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).
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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
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:
Drug: Prednisone
Given PO
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Drug: Thalidomide
Given PO
Other Names:
|
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:
Drug: Melphalan
Given PO
Other Names:
Drug: Prednisone
Given PO
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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
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:
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Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
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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
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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
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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 | |
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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.- NCI-2009-00522
- NCI-2009-00522
- ECOG-E1A06
- CDR0000583984
- E1A06
- E1A06
- E1A06
- U10CA180820
- U10CA021115
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
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. |
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). |
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 |
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
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 |
- NCI-2009-00522
- NCI-2009-00522
- ECOG-E1A06
- CDR0000583984
- E1A06
- E1A06
- E1A06
- U10CA180820
- U10CA021115