S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma
Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00064038
Collaborator
National Cancer Institute (NCI) (NIH)
198
2
2
90
99
1.1
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with previously untreated stage I, stage II, or stage III multiple myeloma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
OBJECTIVES:
-
Compare the progression-free survival of patients with previously untreated stage I, II, or III multiple myeloma treated with dexamethasone with or without lenalidomide.
-
Compare the overall response rate in patients treated with these regimens.
-
Compare the major response rate (indicated by greater than 75% decrease in M-protein) in patients treated with these regimens.
-
Compare the overall survival and time to best response in patients treated with these regimens.
-
Compare the toxicity profile of these regimens, including thrombotic complications, in these patients.
-
Compare the effect of these regimens on gene expression and proteomic analysis in these patients.
OUTLINE: This is a randomized, double-blind, crossover, multicenter study. Patients are stratified according to disease stage by the International Staging System (I vs II vs III) and Zubrod performance status (0-1 vs 2-3). Patients are randomized to 1 of 2 treatment arms.
Arm I
-
Induction therapy: Patients receive oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
-
Maintenance therapy: Patients receive oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II
- Induction therapy: Patients receive DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction.
Patients with responding or stable disease proceed to maintenance therapy. Patients with disease progression during induction therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction. Patients with responding or stable disease after unblinded induction therapy receive unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance.
- Maintenance therapy: Patients receive oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
Patients with disease progression during maintenance therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction. Patients with responding or stable disease after unblinded induction therapy proceed to unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance.
Patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 4 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
198 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients With Previously Untreated Multiple Myeloma
Study Start Date
:
Nov 1, 2004
Actual Primary Completion Date
:
Oct 1, 2008
Actual Study Completion Date
:
May 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Drug: dexamethasone
Given orally
Drug: lenalidomide
Given orally
|
| Active Comparator: Arm II Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance. |
Drug: dexamethasone
Given orally
Other: placebo
Given orally
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival [From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years]
Progression is defined as a > 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc. In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs.
Secondary Outcome Measures
- Toxicity [From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years]
Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
-
Previously untreated multiple myeloma
-
Stage I, II, or III disease by the International Staging System
-
Measurable M-protein as defined by 1 of the following:
-
Serum M-protein at least 1.0 g/dL by serum protein electrophoresis or immunoelectrophoresis
-
Urinary M-protein excretion at least 200 mg/24 hours
-
No nonsecretory multiple myeloma
-
Not planning to undergo future autologous stem cell transplantation
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-3* NOTE: *Zubrod 3 allowed only if multiple myeloma is the central cause of disability
Life expectancy
- Not specified
Hematopoietic
-
Platelet count at least 80,000/mm^3*
-
Absolute neutrophil count at least 1,000/mm^3*
-
Hemoglobin at least 9 g/dL* (epoetin alfa or transfusion allowed) NOTE: *Unless due to greater than 50% marrow involvement by myeloma on biopsy
Hepatic
- AST/ALT no greater than 3 times upper limit of normal* NOTE: *Values outside of this range are allowed at the investigator's discretion
Renal
- Creatinine no greater than 2.5 mg/dL* NOTE: *Values outside of this range are allowed at the investigator's discretion
Cardiovascular
-
No New York Heart Association class III or IV heart failure
-
No myocardial infarction within the past 6 months
-
No poorly controlled hypertension
Other
-
Not pregnant or nursing
-
Negative pregnancy test
-
Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment
-
Female patients must use 2 reliable forms of contraception simultaneously
-
Male patients must use effective barrier contraception
-
No uncontrolled active infection requiring IV antibiotics
-
No poorly controlled diabetes mellitus that would preclude ability to take oral glucocorticoids
-
No other serious medical condition that would preclude study participation
-
No psychiatric illness that would preclude study participation
-
No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
-
Must be able to take aspirin by mouth at a dose of 325 mg per day or enoxaparin subcutaneously at a dose of 40 mg per day as a form of thrombotic prophylaxis, except if already on therapeutic anticoagulant medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior interferon or thalidomide
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Prior high-dose dexamethasone allowed provided duration of administration was no more than 4 days
Radiotherapy
- Prior localized radiotherapy allowed provided it was not to the sole site of evaluable disease
Surgery
- Not specified
Other
-
No prior treatment for clinically significant ventricular cardiac arrhythmias
-
Concurrent bisphosphonates allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | United States | 48073 |
| 2 | Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | United States | 84106 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Jeffrey A. Zonder, MD, Barbara Ann Karmanos Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00064038
Other Study ID Numbers:
- S0232
- U10CA032102
- S0232
First Posted:
Jul 9, 2003
Last Update Posted:
Mar 25, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Southwest Oncology Group
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Between October 15, 2004 and April 2, 2007, 198 patients were enrolled at 41 cooperative medical institutions. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lenalidomide+Dexamethasone | Dexamethasone | Crossover to Lenalidomide+Dexamethasone |
|---|---|---|---|
| Arm/Group Description | Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance. | Patients who have progressive or relapsed disease or who experience unacceptable toxicity attributable to dexamethasone dosing level -2 while on blinded treatment, will be unblinded. Patients shown to have been randomized to DEX + Placebo will proceed with crossover registration and Open-Label Induction with DEX + CC-5013or with open-label CC-5013 alone if they are unblinded due to dexamethasone toxicity. Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Period Title: Initial Randomization | |||
| STARTED | 100 | 98 | 0 |
| Eligible and Analyzable | 97 | 95 | 0 |
| Safety Population | 96 | 94 | 0 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 100 | 98 | 0 |
| Period Title: Initial Randomization | |||
| STARTED | 0 | 0 | 42 |
| Eligible and Analyzable | 0 | 0 | 40 |
| Safety Population | 0 | 0 | 40 |
| COMPLETED | 0 | 0 | 40 |
| NOT COMPLETED | 0 | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Lenalidomide+Dexamethasone | Dexamethasone | Total |
|---|---|---|---|
| Arm/Group Description | Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance. | Total of all reporting groups |
| Overall Participants | 97 | 95 | 192 |
| Age (years) [Median (Full Range) ] | |||
| Overall |
64.9
|
63.1
|
64.6
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
44
45.4%
|
40
42.1%
|
84
43.8%
|
| Male |
53
54.6%
|
55
57.9%
|
108
56.3%
|
Outcome Measures
| Title | Toxicity |
|---|---|
| Description | Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0. |
| Time Frame | From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants receiving at least one dose of induction therapy |
| Arm/Group Title | Lenalidomide and Dexamethasone | Dexamethasone | Crossover to Rev+Dex |
|---|---|---|---|
| Arm/Group Description | Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance. | Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Measure Participants | 96 | 94 | 40 |
| ALT, SGPT (serum glutamic pyruvic transaminase) |
1
1%
|
1
1.1%
|
0
0%
|
| AST, SGOT |
2
2.1%
|
0
0%
|
0
0%
|
| Albumin, serum-low (hypoalbuminemia) |
1
1%
|
0
0%
|
2
1%
|
| Anorexia |
2
2.1%
|
1
1.1%
|
1
0.5%
|
| Apnea |
1
1%
|
0
0%
|
0
0%
|
| Arthritis (non-septic) |
1
1%
|
0
0%
|
0
0%
|
| Aspiration |
1
1%
|
0
0%
|
0
0%
|
| Ataxia (incoordination) |
0
0%
|
1
1.1%
|
0
0%
|
| Bilirubin (hyperbilirubinemia) |
0
0%
|
0
0%
|
1
0.5%
|
| CNS cerebrovascular ischemia |
1
1%
|
2
2.1%
|
2
1%
|
| Calcium, serum-high (hypercalcemia) |
0
0%
|
1
1.1%
|
0
0%
|
| Calcium, serum-low (hypocalcemia) |
7
7.2%
|
2
2.1%
|
3
1.6%
|
| Cardiopulmonary arrest, cause unknown (non-fatal) |
1
1%
|
0
0%
|
0
0%
|
| Cataract |
1
1%
|
1
1.1%
|
2
1%
|
| Cognitive disturbance |
1
1%
|
1
1.1%
|
0
0%
|
| Colitis |
0
0%
|
0
0%
|
1
0.5%
|
| Colitis, infectious (e.g., Clostridium difficile) |
0
0%
|
0
0%
|
1
0.5%
|
| Confusion |
1
1%
|
0
0%
|
0
0%
|
| Constipation |
0
0%
|
2
2.1%
|
1
0.5%
|
| Creatinine |
0
0%
|
0
0%
|
1
0.5%
|
| Cystitis |
0
0%
|
1
1.1%
|
0
0%
|
| Dehydration |
1
1%
|
0
0%
|
3
1.6%
|
| Dermatology/Skin-Other (Specify) |
0
0%
|
1
1.1%
|
0
0%
|
| Diarrhea |
5
5.2%
|
1
1.1%
|
1
0.5%
|
| Dizziness |
1
1%
|
1
1.1%
|
2
1%
|
| Dyspnea (shortness of breath) |
4
4.1%
|
2
2.1%
|
0
0%
|
| Edema: limb |
0
0%
|
1
1.1%
|
2
1%
|
| Encephalopathy |
0
0%
|
0
0%
|
1
0.5%
|
| Fatigue (asthenia, lethargy, malaise) |
19
19.6%
|
12
12.6%
|
8
4.2%
|
| Febrile neutropenia |
1
1%
|
0
0%
|
1
0.5%
|
| Fever in absence of neutropenia, ANC lt1.0x10e9/L |
1
1%
|
1
1.1%
|
0
0%
|
| Fracture |
0
0%
|
1
1.1%
|
0
0%
|
| Gastritis (including bile reflux gastritis) |
0
0%
|
0
0%
|
1
0.5%
|
| Gastrointestinal-Other (Specify) |
1
1%
|
0
0%
|
0
0%
|
| Glomerular filtration rate |
0
0%
|
0
0%
|
1
0.5%
|
| Glucose, serum-high (hyperglycemia) |
5
5.2%
|
18
18.9%
|
2
1%
|
| Glucose, serum-low (hypoglycemia) |
1
1%
|
0
0%
|
0
0%
|
| Heartburn/dyspepsia |
0
0%
|
1
1.1%
|
0
0%
|
| Hemoglobin |
6
6.2%
|
5
5.3%
|
6
3.1%
|
| Hemorrhage, CNS |
1
1%
|
0
0%
|
0
0%
|
| Hemorrhage, GI - Colon |
1
1%
|
0
0%
|
0
0%
|
| Hypertension |
0
0%
|
3
3.2%
|
0
0%
|
| Hypotension |
3
3.1%
|
0
0%
|
0
0%
|
| Hypoxia |
4
4.1%
|
1
1.1%
|
1
0.5%
|
| INR (of prothrombin time) |
1
1%
|
2
2.1%
|
0
0%
|
| Inf (clin/microbio) w/Gr 3-4 neuts - Blood |
1
1%
|
0
0%
|
1
0.5%
|
| Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus |
1
1%
|
0
0%
|
0
0%
|
| Inf (clin/microbio) w/Gr 3-4 neuts - Lung |
5
5.2%
|
0
0%
|
0
0%
|
| Inf (clin/microbio) w/Gr 3-4 neuts - Up aerodigest |
1
1%
|
0
0%
|
0
0%
|
| Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway |
1
1%
|
2
2.1%
|
0
0%
|
| Inf w/normal ANC or Gr 1-2 neutrophils - Bladder |
2
2.1%
|
0
0%
|
0
0%
|
| Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus |
0
0%
|
1
1.1%
|
0
0%
|
| Inf w/normal ANC or Gr 1-2 neutrophils - Colon |
1
1%
|
1
1.1%
|
0
0%
|
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung |
1
1%
|
3
3.2%
|
0
0%
|
| Inf w/normal ANC or Gr 1-2 neutrophils - Skin |
2
2.1%
|
1
1.1%
|
0
0%
|
| Inf w/normal ANC or Gr 1-2 neutrophils - UTI |
2
2.1%
|
2
2.1%
|
0
0%
|
| Inf w/normal ANC or Gr 1-2 neutrophils - Up airway |
3
3.1%
|
1
1.1%
|
0
0%
|
| Inf w/normal ANC or Gr 1-2 neutrophils - Wound |
1
1%
|
0
0%
|
0
0%
|
| Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran |
0
0%
|
0
0%
|
1
0.5%
|
| Infection with unknown ANC - Lung (pneumonia) |
1
1%
|
0
0%
|
0
0%
|
| Infection with unknown ANC - Upper airway NOS |
1
1%
|
1
1.1%
|
0
0%
|
| Infection-Other (Specify) |
0
0%
|
1
1.1%
|
0
0%
|
| Insomnia |
4
4.1%
|
6
6.3%
|
0
0%
|
| Joint-function |
1
1%
|
0
0%
|
0
0%
|
| Left ventricular diastolic dysfunction |
0
0%
|
0
0%
|
1
0.5%
|
| Left ventricular systolic dysfunction |
1
1%
|
0
0%
|
0
0%
|
| Leukocytes (total WBC) |
14
14.4%
|
5
5.3%
|
4
2.1%
|
| Lymphopenia |
10
10.3%
|
5
5.3%
|
8
4.2%
|
| Mood alteration - agitation |
1
1%
|
1
1.1%
|
1
0.5%
|
| Mood alteration - anxiety |
1
1%
|
1
1.1%
|
0
0%
|
| Mood alteration - depression |
11
11.3%
|
8
8.4%
|
2
1%
|
| Mucositis/stomatitis (clinical exam) - Oral cavity |
0
0%
|
1
1.1%
|
0
0%
|
| Muscle weakness, not d/t neuropathy - Extrem-lower |
1
1%
|
3
3.2%
|
1
0.5%
|
| Muscle weakness, not d/t neuropathy - body/general |
9
9.3%
|
4
4.2%
|
3
1.6%
|
| Musculoskeletal/Soft Tissue-Other (Specify) |
0
0%
|
2
2.1%
|
0
0%
|
| Nausea |
2
2.1%
|
1
1.1%
|
0
0%
|
| Neuropathy: motor |
0
0%
|
1
1.1%
|
0
0%
|
| Neuropathy: sensory |
3
3.1%
|
4
4.2%
|
0
0%
|
| Neutrophils/granulocytes (ANC/AGC) |
21
21.6%
|
6
6.3%
|
7
3.6%
|
| Ocular/Visual-Other (Specify) |
1
1%
|
0
0%
|
1
0.5%
|
| Ophthalmoplegia/diplopia (double vision) |
0
0%
|
1
1.1%
|
0
0%
|
| Opportunistic inf associated w/gt=Gr 2 lymphopenia |
2
2.1%
|
0
0%
|
1
0.5%
|
| PTT (Partial thromboplastin time) |
0
0%
|
1
1.1%
|
0
0%
|
| Pain - Abdomen NOS |
0
0%
|
2
2.1%
|
0
0%
|
| Pain - Back |
1
1%
|
2
2.1%
|
1
0.5%
|
| Pain - Bladder |
0
0%
|
0
0%
|
1
0.5%
|
| Pain - Bone |
1
1%
|
3
3.2%
|
0
0%
|
| Pain - Extremity-limb |
1
1%
|
0
0%
|
0
0%
|
| Pain - Head/headache |
0
0%
|
1
1.1%
|
0
0%
|
| Pain - Joint |
3
3.1%
|
1
1.1%
|
0
0%
|
| Pain - Muscle |
3
3.1%
|
1
1.1%
|
1
0.5%
|
| Pain - Pain NOS |
1
1%
|
0
0%
|
0
0%
|
| Pain - Stomach |
0
0%
|
1
1.1%
|
0
0%
|
| Pain-Other (Specify) |
0
0%
|
1
1.1%
|
1
0.5%
|
| Pancreatic endocrine: glucose intolerance |
0
0%
|
1
1.1%
|
0
0%
|
| Perforation, GI - Colon |
1
1%
|
0
0%
|
0
0%
|
| Perforation, GI - Small bowel NOS |
0
0%
|
1
1.1%
|
0
0%
|
| Phosphate, serum-low (hypophosphatemia) |
5
5.2%
|
4
4.2%
|
2
1%
|
| Platelets |
7
7.2%
|
4
4.2%
|
3
1.6%
|
| Pneumonitis/pulmonary infiltrates |
3
3.1%
|
2
2.1%
|
2
1%
|
| Potassium, serum-low (hypokalemia) |
6
6.2%
|
2
2.1%
|
3
1.6%
|
| Prolonged QTc interval |
1
1%
|
0
0%
|
0
0%
|
| Proteinuria |
1
1%
|
0
0%
|
0
0%
|
| Pulmonary/Upper Respiratory-Other (Specify) |
1
1%
|
0
0%
|
0
0%
|
| Rash/desquamation |
1
1%
|
1
1.1%
|
1
0.5%
|
| Rash: acne/acneiform |
0
0%
|
1
1.1%
|
1
0.5%
|
| Rash: erythema multiforme |
0
0%
|
0
0%
|
1
0.5%
|
| Renal failure |
0
0%
|
1
1.1%
|
2
1%
|
| SVT and nodal arrhythmia - Atrial fibrillation |
0
0%
|
2
2.1%
|
0
0%
|
| Sodium, serum-high (hypernatremia) |
0
0%
|
1
1.1%
|
0
0%
|
| Sodium, serum-low (hyponatremia) |
3
3.1%
|
2
2.1%
|
3
1.6%
|
| Somnolence/depressed level of consciousness |
0
0%
|
0
0%
|
1
0.5%
|
| Speech impairment (e.g., dysphasia or aphasia) |
0
0%
|
0
0%
|
1
0.5%
|
| Syncope (fainting) |
1
1%
|
0
0%
|
0
0%
|
| Thrombosis/embolism (vascular access-related) |
2
2.1%
|
0
0%
|
0
0%
|
| Thrombosis/thrombus/embolism |
19
19.6%
|
5
5.3%
|
5
2.6%
|
| Thrombotic microangiopathy |
1
1%
|
0
0%
|
0
0%
|
| Thyroid function, low (hypothyroidism) |
1
1%
|
0
0%
|
0
0%
|
| Tinnitus |
1
1%
|
0
0%
|
0
0%
|
| Vision-blurred vision |
2
2.1%
|
3
3.2%
|
1
0.5%
|
| Vomiting |
2
2.1%
|
1
1.1%
|
0
0%
|
| Weight loss |
0
0%
|
0
0%
|
1
0.5%
|
| Title | Progression-Free Survival |
|---|---|
| Description | Progression is defined as a > 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc. In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs. |
| Time Frame | From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lenalidomide+Dexamethasone | Dexamethasone |
|---|---|---|
| Arm/Group Description | Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance. |
| Measure Participants | 97 | 95 |
| Number (95% Confidence Interval) [percentage of participants] |
78
80.4%
|
52
54.7%
|
Adverse Events
| Time Frame | Report through 1/13/2009 to match data reported in MS. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Lenalidomide and Dexamethasone | Dexamethasone | Crossover to Rev+Dex | |||
| Arm/Group Description | Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance. | Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | |||
All Cause Mortality |
||||||
| Lenalidomide and Dexamethasone | Dexamethasone | Crossover to Rev+Dex | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Lenalidomide and Dexamethasone | Dexamethasone | Crossover to Rev+Dex | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 41/96 (42.7%) | 21/94 (22.3%) | 14/40 (35%) | |||
| Blood and lymphatic system disorders | ||||||
| Hemoglobin | 3/96 (3.1%) | 2/94 (2.1%) | 1/40 (2.5%) | |||
| Cardiac disorders | ||||||
| Cardiac General-Other (Specify) | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Cardiac-ischemia/infarction | 2/96 (2.1%) | 0/94 (0%) | 0/40 (0%) | |||
| Left ventricular diastolic dysfunction | 1/96 (1%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Left ventricular systolic dysfunction | 3/96 (3.1%) | 0/94 (0%) | 0/40 (0%) | |||
| Supraventricular (SVT) and nodal arrhythmia - Atrial fibrillation | 1/96 (1%) | 2/94 (2.1%) | 0/40 (0%) | |||
| SVT and nodal arrhythmia - Atrial tachycardia/paroxysmal atrial tachycardia (PAT) | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Eye disorders | ||||||
| Ocular/Visual-Other (Specify) | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Vision-blurred vision | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Gastrointestinal disorders | ||||||
| Colitis | 1/96 (1%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Constipation | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Diarrhea | 2/96 (2.1%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Dysphagia (difficulty swallowing) | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Fistula, GI - Abdomen, not otherwise specified (NOS) | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Fistula, GI - Colon/cecum/appendix | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Gastritis (including bile reflux gastritis) | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Gastrointestinal-Other (Specify) | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Hemorrhage, GI - Colon | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Hemorrhage, GI - Lower GI NOS | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Nausea | 1/96 (1%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Obstruction, GI - Colon | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Pain - Abdomen NOS | 0/96 (0%) | 2/94 (2.1%) | 0/40 (0%) | |||
| Perforation, GI - Colon | 1/96 (1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Stricture/stenosis (incl anastomotic), Esophagus | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Vomiting | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| General disorders | ||||||
| Death not associated with CTCAE term - Death, not otherwise specified (NOS) | 1/96 (1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Edema: limb | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Extremity-lower (gait/walking) | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Fatigue (asthenia, lethargy, malaise) | 2/96 (2.1%) | 2/94 (2.1%) | 0/40 (0%) | |||
| Pain - Pain NOS | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Sudden death | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Hepatobiliary disorders | ||||||
| Cholecystitis | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Infections and infestations | ||||||
| Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 2/96 (2.1%) | 0/94 (0%) | 0/40 (0%) | |||
| Inf (clin/microbio) w/Gr 3-4 neuts - Up aerodigest | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Inf w/normal absolute neutrophil count (ANC) or Gr 1-2 neutrophils - Ab NOS | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - Bladder | 2/96 (2.1%) | 0/94 (0%) | 0/40 (0%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - Colon | 1/96 (1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 2/96 (2.1%) | 2/94 (2.1%) | 0/40 (0%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 1/96 (1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 2/96 (2.1%) | 2/94 (2.1%) | 0/40 (0%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - Up airway | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Infection with unknown ANC - Lung (pneumonia) | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Infection-Other (Specify) | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Opportunistic inf associated w/gt=Gr 2 lymphopenia | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Fracture | 1/96 (1%) | 3/94 (3.2%) | 0/40 (0%) | |||
| Thrombosis/embolism (vascular access-related) | 2/96 (2.1%) | 0/94 (0%) | 0/40 (0%) | |||
| Investigations | ||||||
| Bilirubin (hyperbilirubinemia) | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Cardiac troponin T (cTnT) | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Creatinine | 3/96 (3.1%) | 0/94 (0%) | 0/40 (0%) | |||
| International normalized ratio (INR) (of prothrombin time) | 1/96 (1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Leukocytes (total white blood cell count (WBC)) | 3/96 (3.1%) | 0/94 (0%) | 0/40 (0%) | |||
| Lymphopenia | 2/96 (2.1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Neutrophils/granulocytes (ANC/AGC) | 3/96 (3.1%) | 0/94 (0%) | 0/40 (0%) | |||
| Platelets | 2/96 (2.1%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Prolonged QTc interval | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Albumin, serum-low (hypoalbuminemia) | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Calcium, serum-low (hypocalcemia) | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Dehydration | 1/96 (1%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Glucose, serum-high (hyperglycemia) | 1/96 (1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Phosphate, serum-low (hypophosphatemia) | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Potassium, serum-low (hypokalemia) | 2/96 (2.1%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Sodium, serum-low (hyponatremia) | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Muscle weakness, not d/t neuropathy - Extrem-lower | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Muscle weakness, not d/t neuropathy - body/general | 4/96 (4.2%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Musculoskeletal/Soft Tissue-Other (Specify) | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Osteonecrosis (avascular necrosis) | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Pain - Back | 3/96 (3.1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Pain - Bone | 1/96 (1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Pain - Extremity-limb | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Death - Disease progression, not otherwise specified (NOS) | 1/96 (1%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Nervous system disorders | ||||||
| Central nervous system (CNS) cerebrovascular ischemia | 1/96 (1%) | 1/94 (1.1%) | 2/40 (5%) | |||
| Dizziness | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Encephalopathy | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Ocular/Visual-Other (Specify) | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Somnolence/depressed level of consciousness | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Speech impairment (e.g., dysphasia or aphasia) | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Syncope (fainting) | 0/96 (0%) | 1/94 (1.1%) | 1/40 (2.5%) | |||
| Psychiatric disorders | ||||||
| Mood alteration - depression | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Renal and urinary disorders | ||||||
| Cystitis | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Glomerular filtration rate | 0/96 (0%) | 0/94 (0%) | 1/40 (2.5%) | |||
| Hemorrhage, GU - Urinary, not otherwise specified (NOS) | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Obstruction, GU - Ureter | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Renal failure | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Aspiration | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Cough | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Dyspnea (shortness of breath) | 2/96 (2.1%) | 1/94 (1.1%) | 2/40 (5%) | |||
| Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Hypoxia | 2/96 (2.1%) | 0/94 (0%) | 0/40 (0%) | |||
| Pain - Pleura | 0/96 (0%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Pneumonitis/pulmonary infiltrates | 5/96 (5.2%) | 2/94 (2.1%) | 1/40 (2.5%) | |||
| Vascular disorders | ||||||
| Hematoma | 1/96 (1%) | 0/94 (0%) | 0/40 (0%) | |||
| Hypotension | 1/96 (1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Phlebitis (including superficial thrombosis) | 1/96 (1%) | 1/94 (1.1%) | 0/40 (0%) | |||
| Thrombosis/thrombus/embolism | 13/96 (13.5%) | 4/94 (4.3%) | 4/40 (10%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Lenalidomide and Dexamethasone | Dexamethasone | Crossover to Rev+Dex | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 91/96 (94.8%) | 90/94 (95.7%) | 39/40 (97.5%) | |||
| Blood and lymphatic system disorders | ||||||
| Hemoglobin | 62/96 (64.6%) | 63/94 (67%) | 31/40 (77.5%) | |||
| Cardiac disorders | ||||||
| Palpitations | 0/96 (0%) | 5/94 (5.3%) | 0/40 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Tinnitus | 0/96 (0%) | 5/94 (5.3%) | 0/40 (0%) | |||
| Eye disorders | ||||||
| Cataract | 6/96 (6.3%) | 0/94 (0%) | 3/40 (7.5%) | |||
| Ocular/Visual-Other (Specify) | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Vision-blurred vision | 12/96 (12.5%) | 9/94 (9.6%) | 5/40 (12.5%) | |||
| Gastrointestinal disorders | ||||||
| Constipation | 43/96 (44.8%) | 34/94 (36.2%) | 19/40 (47.5%) | |||
| Diarrhea | 44/96 (45.8%) | 29/94 (30.9%) | 9/40 (22.5%) | |||
| Distention/bloating, abdominal | 0/96 (0%) | 5/94 (5.3%) | 0/40 (0%) | |||
| Dysphagia (difficulty swallowing) | 0/96 (0%) | 8/94 (8.5%) | 0/40 (0%) | |||
| Heartburn/dyspepsia | 18/96 (18.8%) | 12/94 (12.8%) | 2/40 (5%) | |||
| Mucositis/stomatitis (clinical exam) - Oral cavity | 7/96 (7.3%) | 10/94 (10.6%) | 5/40 (12.5%) | |||
| Mucositis/stomatitis (functional/symp) - Oral cav | 7/96 (7.3%) | 11/94 (11.7%) | 0/40 (0%) | |||
| Nausea | 36/96 (37.5%) | 24/94 (25.5%) | 11/40 (27.5%) | |||
| Pain - Abdomen, not otherwise specified (NOS) | 9/96 (9.4%) | 7/94 (7.4%) | 3/40 (7.5%) | |||
| Pain - Dental/teeth/peridontal | 0/96 (0%) | 0/94 (0%) | 3/40 (7.5%) | |||
| Vomiting | 11/96 (11.5%) | 10/94 (10.6%) | 0/40 (0%) | |||
| General disorders | ||||||
| Edema: head and neck | 0/96 (0%) | 13/94 (13.8%) | 0/40 (0%) | |||
| Edema: limb | 36/96 (37.5%) | 35/94 (37.2%) | 13/40 (32.5%) | |||
| Fatigue (asthenia, lethargy, malaise) | 74/96 (77.1%) | 71/94 (75.5%) | 31/40 (77.5%) | |||
| Fever in absence of neutropenia, ANC lt1.0x10e9/L | 7/96 (7.3%) | 15/94 (16%) | 3/40 (7.5%) | |||
| Pain - Chest/thorax NOS | 8/96 (8.3%) | 8/94 (8.5%) | 3/40 (7.5%) | |||
| Pain-Other (Specify) | 5/96 (5.2%) | 0/94 (0%) | 3/40 (7.5%) | |||
| Rigors/chills | 6/96 (6.3%) | 8/94 (8.5%) | 2/40 (5%) | |||
| Infections and infestations | ||||||
| Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | 0/96 (0%) | 5/94 (5.3%) | 0/40 (0%) | |||
| Inf w/normal absolute neutrophil count (ANC) or Gr 1-2 neutrophils - Bronchus | 0/96 (0%) | 0/94 (0%) | 3/40 (7.5%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 5/96 (5.2%) | 0/94 (0%) | 0/40 (0%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 9/96 (9.4%) | 5/94 (5.3%) | 2/40 (5%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 0/96 (0%) | 0/94 (0%) | 4/40 (10%) | |||
| Inf w/normal ANC or Gr 1-2 neutrophils - Up airway | 23/96 (24%) | 15/94 (16%) | 5/40 (12.5%) | |||
| Infection with unknown ANC - Sinus | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Infection with unknown ANC - Skin (cellulitis) | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Infection with unknown ANC - Upper airway, not otherwise specified (NOS) | 6/96 (6.3%) | 0/94 (0%) | 0/40 (0%) | |||
| Infection with unknown ANC - Urinary tract NOS | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Injury, poisoning and procedural complications | ||||||
| Bruising (in absence of Gr 3-4 thrombocytopenia) | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Investigations | ||||||
| Alanine aminotransferase (ALT), serum glutamic pyruvic transaminase (SGPT) | 17/96 (17.7%) | 14/94 (14.9%) | 4/40 (10%) | |||
| Aspartate aminotransferase (AST), serum glutamic oxaloacetic transaminase (SGOT) | 12/96 (12.5%) | 11/94 (11.7%) | 7/40 (17.5%) | |||
| Alkaline phosphatase | 17/96 (17.7%) | 10/94 (10.6%) | 4/40 (10%) | |||
| Bilirubin (hyperbilirubinemia) | 10/96 (10.4%) | 5/94 (5.3%) | 4/40 (10%) | |||
| Creatinine | 22/96 (22.9%) | 20/94 (21.3%) | 12/40 (30%) | |||
| Leukocytes (total WBC) | 51/96 (53.1%) | 28/94 (29.8%) | 20/40 (50%) | |||
| Lymphopenia | 28/96 (29.2%) | 24/94 (25.5%) | 16/40 (40%) | |||
| Metabolic/Laboratory-Other (Specify) | 0/96 (0%) | 6/94 (6.4%) | 2/40 (5%) | |||
| Neutrophils/granulocytes (ANC/AGC) | 42/96 (43.8%) | 22/94 (23.4%) | 15/40 (37.5%) | |||
| Platelets | 35/96 (36.5%) | 24/94 (25.5%) | 16/40 (40%) | |||
| Weight gain | 7/96 (7.3%) | 8/94 (8.5%) | 4/40 (10%) | |||
| Weight loss | 22/96 (22.9%) | 14/94 (14.9%) | 3/40 (7.5%) | |||
| Metabolism and nutrition disorders | ||||||
| Albumin, serum-low (hypoalbuminemia) | 24/96 (25%) | 21/94 (22.3%) | 13/40 (32.5%) | |||
| Anorexia | 24/96 (25%) | 20/94 (21.3%) | 11/40 (27.5%) | |||
| Calcium, serum-high (hypercalcemia) | 5/96 (5.2%) | 11/94 (11.7%) | 2/40 (5%) | |||
| Calcium, serum-low (hypocalcemia) | 43/96 (44.8%) | 38/94 (40.4%) | 19/40 (47.5%) | |||
| Dehydration | 10/96 (10.4%) | 12/94 (12.8%) | 7/40 (17.5%) | |||
| Glucose, serum-high (hyperglycemia) | 53/96 (55.2%) | 59/94 (62.8%) | 22/40 (55%) | |||
| Glucose, serum-low (hypoglycemia) | 9/96 (9.4%) | 0/94 (0%) | 3/40 (7.5%) | |||
| Magnesium, serum-low (hypomagnesemia) | 12/96 (12.5%) | 9/94 (9.6%) | 2/40 (5%) | |||
| Phosphate, serum-low (hypophosphatemia) | 14/96 (14.6%) | 9/94 (9.6%) | 5/40 (12.5%) | |||
| Potassium, serum-high (hyperkalemia) | 0/96 (0%) | 10/94 (10.6%) | 2/40 (5%) | |||
| Potassium, serum-low (hypokalemia) | 35/96 (36.5%) | 21/94 (22.3%) | 18/40 (45%) | |||
| Sodium, serum-high (hypernatremia) | 6/96 (6.3%) | 5/94 (5.3%) | 0/40 (0%) | |||
| Sodium, serum-low (hyponatremia) | 11/96 (11.5%) | 23/94 (24.5%) | 8/40 (20%) | |||
| Triglyceride, serum-high (hypertriglyceridemia) | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthritis (non-septic) | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Muscle weakness, not d/t neuropathy - Extrem-lower | 5/96 (5.2%) | 8/94 (8.5%) | 4/40 (10%) | |||
| Muscle weakness, not d/t neuropathy - body/general | 23/96 (24%) | 15/94 (16%) | 5/40 (12.5%) | |||
| Musculoskeletal/Soft Tissue-Other (Specify) | 0/96 (0%) | 0/94 (0%) | 3/40 (7.5%) | |||
| Osteonecrosis (avascular necrosis) | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Pain - Back | 34/96 (35.4%) | 25/94 (26.6%) | 13/40 (32.5%) | |||
| Pain - Bone | 16/96 (16.7%) | 21/94 (22.3%) | 8/40 (20%) | |||
| Pain - Extremity-limb | 14/96 (14.6%) | 12/94 (12.8%) | 6/40 (15%) | |||
| Pain - Joint | 21/96 (21.9%) | 21/94 (22.3%) | 12/40 (30%) | |||
| Pain - Muscle | 21/96 (21.9%) | 12/94 (12.8%) | 10/40 (25%) | |||
| Pain - Neck | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Nervous system disorders | ||||||
| Dizziness | 22/96 (22.9%) | 18/94 (19.1%) | 8/40 (20%) | |||
| Memory impairment | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Neuropathy: motor | 5/96 (5.2%) | 8/94 (8.5%) | 4/40 (10%) | |||
| Neuropathy: sensory | 49/96 (51%) | 32/94 (34%) | 9/40 (22.5%) | |||
| Ocular/Visual-Other (Specify) | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Pain - Head/headache | 13/96 (13.5%) | 12/94 (12.8%) | 5/40 (12.5%) | |||
| Taste alteration (dysgeusia) | 26/96 (27.1%) | 15/94 (16%) | 5/40 (12.5%) | |||
| Tremor | 10/96 (10.4%) | 10/94 (10.6%) | 2/40 (5%) | |||
| Psychiatric disorders | ||||||
| Confusion | 7/96 (7.3%) | 8/94 (8.5%) | 2/40 (5%) | |||
| Insomnia | 34/96 (35.4%) | 49/94 (52.1%) | 8/40 (20%) | |||
| Mood alteration - agitation | 7/96 (7.3%) | 9/94 (9.6%) | 2/40 (5%) | |||
| Mood alteration - anxiety | 10/96 (10.4%) | 9/94 (9.6%) | 0/40 (0%) | |||
| Mood alteration - depression | 30/96 (31.3%) | 23/94 (24.5%) | 9/40 (22.5%) | |||
| Renal and urinary disorders | ||||||
| Incontinence, urinary | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Pain - Bladder | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Proteinuria | 0/96 (0%) | 0/94 (0%) | 3/40 (7.5%) | |||
| Urinary frequency/urgency | 0/96 (0%) | 7/94 (7.4%) | 0/40 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 15/96 (15.6%) | 15/94 (16%) | 5/40 (12.5%) | |||
| Dyspnea (shortness of breath) | 19/96 (19.8%) | 18/94 (19.1%) | 0/40 (0%) | |||
| Hemorrhage, pulmonary/upper respiratory - Nose | 0/96 (0%) | 5/94 (5.3%) | 2/40 (5%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dermatology/Skin-Other (Specify) | 5/96 (5.2%) | 11/94 (11.7%) | 2/40 (5%) | |||
| Dry skin | 7/96 (7.3%) | 0/94 (0%) | 0/40 (0%) | |||
| Hair loss/Alopecia (scalp or body) | 6/96 (6.3%) | 5/94 (5.3%) | 0/40 (0%) | |||
| Photosensitivity | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Rash/desquamation | 22/96 (22.9%) | 17/94 (18.1%) | 11/40 (27.5%) | |||
| Rash: acne/acneiform | 0/96 (0%) | 0/94 (0%) | 4/40 (10%) | |||
| Sweating (diaphoresis) | 10/96 (10.4%) | 13/94 (13.8%) | 2/40 (5%) | |||
| Ulceration | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Vascular disorders | ||||||
| Flushing | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Hot flashes/flushes | 0/96 (0%) | 0/94 (0%) | 2/40 (5%) | |||
| Hypertension | 9/96 (9.4%) | 8/94 (8.5%) | 2/40 (5%) | |||
| Hypotension | 12/96 (12.5%) | 5/94 (5.3%) | 0/40 (0%) | |||
| Thrombosis/thrombus/embolism | 10/96 (10.4%) | 0/94 (0%) | 6/40 (15%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Robert Z. Orlowski, MD, PhD |
|---|---|
| Organization | SWOG |
| Phone | (713) 792-2860 |
| rorlowsk@mdanderson.org |
Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00064038
Other Study ID Numbers:
- S0232
- U10CA032102
- S0232
First Posted:
Jul 9, 2003
Last Update Posted:
Mar 25, 2015
Last Verified:
Mar 1, 2015