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Trial record 22 of 2513 for:    "Plasma Cell Neoplasm"

S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00064038
Recruitment Status : Completed
First Posted : July 9, 2003
Results First Posted : July 17, 2013
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Multiple Myeloma
Plasma Cell Neoplasm
Interventions Drug: dexamethasone
Drug: lenalidomide
Other: placebo
Enrollment 198
Recruitment Details Between October 15, 2004 and April 2, 2007, 198 patients were enrolled at 41 cooperative medical institutions.
Pre-assignment Details  
Arm/Group Title Lenalidomide+Dexamethasone Dexamethasone Crossover to Lenalidomide+Dexamethasone
Hide 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 [1] 0 [1] 0
Not Completed 100 98 0
[1]
The study was closed early per recommedation of the Data Safety Monitoring Committee.
Period Title: Crossover to Lenalidomide+Dexamethasone
Started 0 0 [1] 42
Eligible and Analyzable 0 0 [1] 40
Safety Population 0 0 [1] 40
Completed 0 0 [1] 40
Not Completed 0 0 2
[1]
See Crossover to Lenalidomide+Dexamethasone Arm.
Arm/Group Title Lenalidomide+Dexamethasone Dexamethasone Total
Hide 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 Number of Baseline Participants 97 95 192
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Overall Number Analyzed 97 participants 95 participants 192 participants
64.9
(36.9 to 89.0)
63.1
(37.6 to 87.0)
64.6
(36.9 to 89.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 95 participants 192 participants
Female
44
  45.4%
40
  42.1%
84
  43.8%
Male
53
  54.6%
55
  57.9%
108
  56.3%
1.Primary Outcome
Title Progression-Free Survival
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide+Dexamethasone Dexamethasone
Hide 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.
Overall Number of Participants Analyzed 97 95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78
(70 to 78)
52
(41 to 62)
2.Secondary Outcome
Title Toxicity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one dose of induction therapy
Arm/Group Title Lenalidomide and Dexamethasone Dexamethasone Crossover to Rev+Dex
Hide 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.
Overall Number of Participants Analyzed 96 94 40
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 1 1 0
AST, SGOT 2 0 0
Albumin, serum-low (hypoalbuminemia) 1 0 2
Anorexia 2 1 1
Apnea 1 0 0
Arthritis (non-septic) 1 0 0
Aspiration 1 0 0
Ataxia (incoordination) 0 1 0
Bilirubin (hyperbilirubinemia) 0 0 1
CNS cerebrovascular ischemia 1 2 2
Calcium, serum-high (hypercalcemia) 0 1 0
Calcium, serum-low (hypocalcemia) 7 2 3
Cardiopulmonary arrest, cause unknown (non-fatal) 1 0 0
Cataract 1 1 2
Cognitive disturbance 1 1 0
Colitis 0 0 1
Colitis, infectious (e.g., Clostridium difficile) 0 0 1
Confusion 1 0 0
Constipation 0 2 1
Creatinine 0 0 1
Cystitis 0 1 0
Dehydration 1 0 3
Dermatology/Skin-Other (Specify) 0 1 0
Diarrhea 5 1 1
Dizziness 1 1 2
Dyspnea (shortness of breath) 4 2 0
Edema: limb 0 1 2
Encephalopathy 0 0 1
Fatigue (asthenia, lethargy, malaise) 19 12 8
Febrile neutropenia 1 0 1
Fever in absence of neutropenia, ANC lt1.0x10e9/L 1 1 0
Fracture 0 1 0
Gastritis (including bile reflux gastritis) 0 0 1
Gastrointestinal-Other (Specify) 1 0 0
Glomerular filtration rate 0 0 1
Glucose, serum-high (hyperglycemia) 5 18 2
Glucose, serum-low (hypoglycemia) 1 0 0
Heartburn/dyspepsia 0 1 0
Hemoglobin 6 5 6
Hemorrhage, CNS 1 0 0
Hemorrhage, GI - Colon 1 0 0
Hypertension 0 3 0
Hypotension 3 0 0
Hypoxia 4 1 1
INR (of prothrombin time) 1 2 0
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 1 0 1
Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Lung 5 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Up aerodigest 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway 1 2 0
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder 2 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus 0 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Colon 1 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Lung 1 3 0
Inf w/normal ANC or Gr 1-2 neutrophils - Skin 2 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - UTI 2 2 0
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway 3 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Wound 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran 0 0 1
Infection with unknown ANC - Lung (pneumonia) 1 0 0
Infection with unknown ANC - Upper airway NOS 1 1 0
Infection-Other (Specify) 0 1 0
Insomnia 4 6 0
Joint-function 1 0 0
Left ventricular diastolic dysfunction 0 0 1
Left ventricular systolic dysfunction 1 0 0
Leukocytes (total WBC) 14 5 4
Lymphopenia 10 5 8
Mood alteration - agitation 1 1 1
Mood alteration - anxiety 1 1 0
Mood alteration - depression 11 8 2
Mucositis/stomatitis (clinical exam) - Oral cavity 0 1 0
Muscle weakness, not d/t neuropathy - Extrem-lower 1 3 1
Muscle weakness, not d/t neuropathy - body/general 9 4 3
Musculoskeletal/Soft Tissue-Other (Specify) 0 2 0
Nausea 2 1 0
Neuropathy: motor 0 1 0
Neuropathy: sensory 3 4 0
Neutrophils/granulocytes (ANC/AGC) 21 6 7
Ocular/Visual-Other (Specify) 1 0 1
Ophthalmoplegia/diplopia (double vision) 0 1 0
Opportunistic inf associated w/gt=Gr 2 lymphopenia 2 0 1
PTT (Partial thromboplastin time) 0 1 0
Pain - Abdomen NOS 0 2 0
Pain - Back 1 2 1
Pain - Bladder 0 0 1
Pain - Bone 1 3 0
Pain - Extremity-limb 1 0 0
Pain - Head/headache 0 1 0
Pain - Joint 3 1 0
Pain - Muscle 3 1 1
Pain - Pain NOS 1 0 0
Pain - Stomach 0 1 0
Pain-Other (Specify) 0 1 1
Pancreatic endocrine: glucose intolerance 0 1 0
Perforation, GI - Colon 1 0 0
Perforation, GI - Small bowel NOS 0 1 0
Phosphate, serum-low (hypophosphatemia) 5 4 2
Platelets 7 4 3
Pneumonitis/pulmonary infiltrates 3 2 2
Potassium, serum-low (hypokalemia) 6 2 3
Prolonged QTc interval 1 0 0
Proteinuria 1 0 0
Pulmonary/Upper Respiratory-Other (Specify) 1 0 0
Rash/desquamation 1 1 1
Rash: acne/acneiform 0 1 1
Rash: erythema multiforme 0 0 1
Renal failure 0 1 2
SVT and nodal arrhythmia - Atrial fibrillation 0 2 0
Sodium, serum-high (hypernatremia) 0 1 0
Sodium, serum-low (hyponatremia) 3 2 3
Somnolence/depressed level of consciousness 0 0 1
Speech impairment (e.g., dysphasia or aphasia) 0 0 1
Syncope (fainting) 1 0 0
Thrombosis/embolism (vascular access-related) 2 0 0
Thrombosis/thrombus/embolism 19 5 5
Thrombotic microangiopathy 1 0 0
Thyroid function, low (hypothyroidism) 1 0 0
Tinnitus 1 0 0
Vision-blurred vision 2 3 1
Vomiting 2 1 0
Weight loss 0 0 1
Time Frame Report through 1/13/2009 to match data reported in MS.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide and Dexamethasone Dexamethasone Crossover to Rev+Dex
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide and Dexamethasone Dexamethasone Crossover to Rev+Dex
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/96 (42.71%)   21/94 (22.34%)   14/40 (35.00%) 
Blood and lymphatic system disorders       
Hemoglobin  1  3/96 (3.13%)  2/94 (2.13%)  1/40 (2.50%) 
Cardiac disorders       
Cardiac General-Other (Specify)  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Cardiac-ischemia/infarction  1  2/96 (2.08%)  0/94 (0.00%)  0/40 (0.00%) 
Left ventricular diastolic dysfunction  1  1/96 (1.04%)  0/94 (0.00%)  1/40 (2.50%) 
Left ventricular systolic dysfunction  1  3/96 (3.13%)  0/94 (0.00%)  0/40 (0.00%) 
Supraventricular (SVT) and nodal arrhythmia - Atrial fibrillation  1  1/96 (1.04%)  2/94 (2.13%)  0/40 (0.00%) 
SVT and nodal arrhythmia - Atrial tachycardia/paroxysmal atrial tachycardia (PAT)  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Eye disorders       
Ocular/Visual-Other (Specify)  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Vision-blurred vision  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Gastrointestinal disorders       
Colitis  1  1/96 (1.04%)  0/94 (0.00%)  1/40 (2.50%) 
Constipation  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Diarrhea  1  2/96 (2.08%)  0/94 (0.00%)  1/40 (2.50%) 
Dysphagia (difficulty swallowing)  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Fistula, GI - Abdomen, not otherwise specified (NOS)  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Fistula, GI - Colon/cecum/appendix  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Gastritis (including bile reflux gastritis)  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Gastrointestinal-Other (Specify)  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Hemorrhage, GI - Colon  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Hemorrhage, GI - Lower GI NOS  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Nausea  1  1/96 (1.04%)  0/94 (0.00%)  1/40 (2.50%) 
Obstruction, GI - Colon  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Pain - Abdomen NOS  1  0/96 (0.00%)  2/94 (2.13%)  0/40 (0.00%) 
Perforation, GI - Colon  1  1/96 (1.04%)  1/94 (1.06%)  0/40 (0.00%) 
Stricture/stenosis (incl anastomotic), Esophagus  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Vomiting  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
General disorders       
Death not associated with CTCAE term - Death, not otherwise specified (NOS)  1  1/96 (1.04%)  1/94 (1.06%)  0/40 (0.00%) 
Edema: limb  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Extremity-lower (gait/walking)  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Fatigue (asthenia, lethargy, malaise)  1  2/96 (2.08%)  2/94 (2.13%)  0/40 (0.00%) 
Pain - Pain NOS  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Sudden death  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Infections and infestations       
Inf (clin/microbio) w/Gr 3-4 neuts - Blood  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Lung  1  2/96 (2.08%)  0/94 (0.00%)  0/40 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Up aerodigest  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Inf w/normal absolute neutrophil count (ANC) or Gr 1-2 neutrophils - Ab NOS  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder  1  2/96 (2.08%)  0/94 (0.00%)  0/40 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Colon  1  1/96 (1.04%)  1/94 (1.06%)  0/40 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  2/96 (2.08%)  2/94 (2.13%)  0/40 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  1/96 (1.04%)  1/94 (1.06%)  0/40 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  2/96 (2.08%)  2/94 (2.13%)  0/40 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Infection with unknown ANC - Lung (pneumonia)  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Infection-Other (Specify)  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Opportunistic inf associated w/gt=Gr 2 lymphopenia  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Injury, poisoning and procedural complications       
Fracture  1  1/96 (1.04%)  3/94 (3.19%)  0/40 (0.00%) 
Thrombosis/embolism (vascular access-related)  1  2/96 (2.08%)  0/94 (0.00%)  0/40 (0.00%) 
Investigations       
Bilirubin (hyperbilirubinemia)  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Cardiac troponin T (cTnT)  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Creatinine  1  3/96 (3.13%)  0/94 (0.00%)  0/40 (0.00%) 
International normalized ratio‎ (INR) (of prothrombin time)  1  1/96 (1.04%)  1/94 (1.06%)  0/40 (0.00%) 
Leukocytes (total white blood cell count (WBC))  1  3/96 (3.13%)  0/94 (0.00%)  0/40 (0.00%) 
Lymphopenia  1  2/96 (2.08%)  1/94 (1.06%)  0/40 (0.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  3/96 (3.13%)  0/94 (0.00%)  0/40 (0.00%) 
Platelets  1  2/96 (2.08%)  0/94 (0.00%)  1/40 (2.50%) 
Prolonged QTc interval  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Metabolism and nutrition disorders       
Albumin, serum-low (hypoalbuminemia)  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Calcium, serum-low (hypocalcemia)  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Dehydration  1  1/96 (1.04%)  0/94 (0.00%)  1/40 (2.50%) 
Glucose, serum-high (hyperglycemia)  1  1/96 (1.04%)  1/94 (1.06%)  0/40 (0.00%) 
Phosphate, serum-low (hypophosphatemia)  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Potassium, serum-low (hypokalemia)  1  2/96 (2.08%)  0/94 (0.00%)  1/40 (2.50%) 
Sodium, serum-low (hyponatremia)  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Musculoskeletal and connective tissue disorders       
Muscle weakness, not d/t neuropathy - Extrem-lower  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Muscle weakness, not d/t neuropathy - body/general  1  4/96 (4.17%)  0/94 (0.00%)  1/40 (2.50%) 
Musculoskeletal/Soft Tissue-Other (Specify)  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Osteonecrosis (avascular necrosis)  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Pain - Back  1  3/96 (3.13%)  1/94 (1.06%)  0/40 (0.00%) 
Pain - Bone  1  1/96 (1.04%)  1/94 (1.06%)  0/40 (0.00%) 
Pain - Extremity-limb  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Death - Disease progression, not otherwise specified (NOS)  1  1/96 (1.04%)  0/94 (0.00%)  1/40 (2.50%) 
Nervous system disorders       
Central nervous system (CNS) cerebrovascular ischemia  1  1/96 (1.04%)  1/94 (1.06%)  2/40 (5.00%) 
Dizziness  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Encephalopathy  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Ocular/Visual-Other (Specify)  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Somnolence/depressed level of consciousness  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Speech impairment (e.g., dysphasia or aphasia)  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Syncope (fainting)  1  0/96 (0.00%)  1/94 (1.06%)  1/40 (2.50%) 
Psychiatric disorders       
Mood alteration - depression  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Renal and urinary disorders       
Cystitis  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Glomerular filtration rate  1  0/96 (0.00%)  0/94 (0.00%)  1/40 (2.50%) 
Hemorrhage, GU - Urinary, not otherwise specified (NOS)  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Obstruction, GU - Ureter  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Renal failure  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders       
Aspiration  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Cough  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Dyspnea (shortness of breath)  1  2/96 (2.08%)  1/94 (1.06%)  2/40 (5.00%) 
Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Hypoxia  1  2/96 (2.08%)  0/94 (0.00%)  0/40 (0.00%) 
Pain - Pleura  1  0/96 (0.00%)  1/94 (1.06%)  0/40 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  5/96 (5.21%)  2/94 (2.13%)  1/40 (2.50%) 
Vascular disorders       
Hematoma  1  1/96 (1.04%)  0/94 (0.00%)  0/40 (0.00%) 
Hypotension  1  1/96 (1.04%)  1/94 (1.06%)  0/40 (0.00%) 
Phlebitis (including superficial thrombosis)  1  1/96 (1.04%)  1/94 (1.06%)  0/40 (0.00%) 
Thrombosis/thrombus/embolism  1  13/96 (13.54%)  4/94 (4.26%)  4/40 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide and Dexamethasone Dexamethasone Crossover to Rev+Dex
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   91/96 (94.79%)   90/94 (95.74%)   39/40 (97.50%) 
Blood and lymphatic system disorders       
Hemoglobin  1  62/96 (64.58%)  63/94 (67.02%)  31/40 (77.50%) 
Cardiac disorders       
Palpitations  1  0/96 (0.00%)  5/94 (5.32%)  0/40 (0.00%) 
Ear and labyrinth disorders       
Tinnitus  1  0/96 (0.00%)  5/94 (5.32%)  0/40 (0.00%) 
Eye disorders       
Cataract  1  6/96 (6.25%)  0/94 (0.00%)  3/40 (7.50%) 
Ocular/Visual-Other (Specify)  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Vision-blurred vision  1  12/96 (12.50%)  9/94 (9.57%)  5/40 (12.50%) 
Gastrointestinal disorders       
Constipation  1  43/96 (44.79%)  34/94 (36.17%)  19/40 (47.50%) 
Diarrhea  1  44/96 (45.83%)  29/94 (30.85%)  9/40 (22.50%) 
Distention/bloating, abdominal  1  0/96 (0.00%)  5/94 (5.32%)  0/40 (0.00%) 
Dysphagia (difficulty swallowing)  1  0/96 (0.00%)  8/94 (8.51%)  0/40 (0.00%) 
Heartburn/dyspepsia  1  18/96 (18.75%)  12/94 (12.77%)  2/40 (5.00%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  7/96 (7.29%)  10/94 (10.64%)  5/40 (12.50%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  7/96 (7.29%)  11/94 (11.70%)  0/40 (0.00%) 
Nausea  1  36/96 (37.50%)  24/94 (25.53%)  11/40 (27.50%) 
Pain - Abdomen, not otherwise specified (NOS)  1  9/96 (9.38%)  7/94 (7.45%)  3/40 (7.50%) 
Pain - Dental/teeth/peridontal  1  0/96 (0.00%)  0/94 (0.00%)  3/40 (7.50%) 
Vomiting  1  11/96 (11.46%)  10/94 (10.64%)  0/40 (0.00%) 
General disorders       
Edema: head and neck  1  0/96 (0.00%)  13/94 (13.83%)  0/40 (0.00%) 
Edema: limb  1  36/96 (37.50%)  35/94 (37.23%)  13/40 (32.50%) 
Fatigue (asthenia, lethargy, malaise)  1  74/96 (77.08%)  71/94 (75.53%)  31/40 (77.50%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  7/96 (7.29%)  15/94 (15.96%)  3/40 (7.50%) 
Pain - Chest/thorax NOS  1  8/96 (8.33%)  8/94 (8.51%)  3/40 (7.50%) 
Pain-Other (Specify)  1  5/96 (5.21%)  0/94 (0.00%)  3/40 (7.50%) 
Rigors/chills  1  6/96 (6.25%)  8/94 (8.51%)  2/40 (5.00%) 
Infections and infestations       
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway  1  0/96 (0.00%)  5/94 (5.32%)  0/40 (0.00%) 
Inf w/normal absolute neutrophil count (ANC) or Gr 1-2 neutrophils - Bronchus  1  0/96 (0.00%)  0/94 (0.00%)  3/40 (7.50%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  5/96 (5.21%)  0/94 (0.00%)  0/40 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  9/96 (9.38%)  5/94 (5.32%)  2/40 (5.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  0/96 (0.00%)  0/94 (0.00%)  4/40 (10.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway  1  23/96 (23.96%)  15/94 (15.96%)  5/40 (12.50%) 
Infection with unknown ANC - Sinus  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Infection with unknown ANC - Skin (cellulitis)  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Infection with unknown ANC - Upper airway, not otherwise specified (NOS)  1  6/96 (6.25%)  0/94 (0.00%)  0/40 (0.00%) 
Infection with unknown ANC - Urinary tract NOS  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Injury, poisoning and procedural complications       
Bruising (in absence of Gr 3-4 thrombocytopenia)  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Investigations       
Alanine aminotransferase (ALT), serum glutamic pyruvic transaminase (SGPT)  1  17/96 (17.71%)  14/94 (14.89%)  4/40 (10.00%) 
Aspartate aminotransferase (AST), serum glutamic oxaloacetic transaminase (SGOT)  1  12/96 (12.50%)  11/94 (11.70%)  7/40 (17.50%) 
Alkaline phosphatase  1  17/96 (17.71%)  10/94 (10.64%)  4/40 (10.00%) 
Bilirubin (hyperbilirubinemia)  1  10/96 (10.42%)  5/94 (5.32%)  4/40 (10.00%) 
Creatinine  1  22/96 (22.92%)  20/94 (21.28%)  12/40 (30.00%) 
Leukocytes (total WBC)  1  51/96 (53.13%)  28/94 (29.79%)  20/40 (50.00%) 
Lymphopenia  1  28/96 (29.17%)  24/94 (25.53%)  16/40 (40.00%) 
Metabolic/Laboratory-Other (Specify)  1  0/96 (0.00%)  6/94 (6.38%)  2/40 (5.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  42/96 (43.75%)  22/94 (23.40%)  15/40 (37.50%) 
Platelets  1  35/96 (36.46%)  24/94 (25.53%)  16/40 (40.00%) 
Weight gain  1  7/96 (7.29%)  8/94 (8.51%)  4/40 (10.00%) 
Weight loss  1  22/96 (22.92%)  14/94 (14.89%)  3/40 (7.50%) 
Metabolism and nutrition disorders       
Albumin, serum-low (hypoalbuminemia)  1  24/96 (25.00%)  21/94 (22.34%)  13/40 (32.50%) 
Anorexia  1  24/96 (25.00%)  20/94 (21.28%)  11/40 (27.50%) 
Calcium, serum-high (hypercalcemia)  1  5/96 (5.21%)  11/94 (11.70%)  2/40 (5.00%) 
Calcium, serum-low (hypocalcemia)  1  43/96 (44.79%)  38/94 (40.43%)  19/40 (47.50%) 
Dehydration  1  10/96 (10.42%)  12/94 (12.77%)  7/40 (17.50%) 
Glucose, serum-high (hyperglycemia)  1  53/96 (55.21%)  59/94 (62.77%)  22/40 (55.00%) 
Glucose, serum-low (hypoglycemia)  1  9/96 (9.38%)  0/94 (0.00%)  3/40 (7.50%) 
Magnesium, serum-low (hypomagnesemia)  1  12/96 (12.50%)  9/94 (9.57%)  2/40 (5.00%) 
Phosphate, serum-low (hypophosphatemia)  1  14/96 (14.58%)  9/94 (9.57%)  5/40 (12.50%) 
Potassium, serum-high (hyperkalemia)  1  0/96 (0.00%)  10/94 (10.64%)  2/40 (5.00%) 
Potassium, serum-low (hypokalemia)  1  35/96 (36.46%)  21/94 (22.34%)  18/40 (45.00%) 
Sodium, serum-high (hypernatremia)  1  6/96 (6.25%)  5/94 (5.32%)  0/40 (0.00%) 
Sodium, serum-low (hyponatremia)  1  11/96 (11.46%)  23/94 (24.47%)  8/40 (20.00%) 
Triglyceride, serum-high (hypertriglyceridemia)  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis (non-septic)  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Muscle weakness, not d/t neuropathy - Extrem-lower  1  5/96 (5.21%)  8/94 (8.51%)  4/40 (10.00%) 
Muscle weakness, not d/t neuropathy - body/general  1  23/96 (23.96%)  15/94 (15.96%)  5/40 (12.50%) 
Musculoskeletal/Soft Tissue-Other (Specify)  1  0/96 (0.00%)  0/94 (0.00%)  3/40 (7.50%) 
Osteonecrosis (avascular necrosis)  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Pain - Back  1  34/96 (35.42%)  25/94 (26.60%)  13/40 (32.50%) 
Pain - Bone  1  16/96 (16.67%)  21/94 (22.34%)  8/40 (20.00%) 
Pain - Extremity-limb  1  14/96 (14.58%)  12/94 (12.77%)  6/40 (15.00%) 
Pain - Joint  1  21/96 (21.88%)  21/94 (22.34%)  12/40 (30.00%) 
Pain - Muscle  1  21/96 (21.88%)  12/94 (12.77%)  10/40 (25.00%) 
Pain - Neck  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Nervous system disorders       
Dizziness  1  22/96 (22.92%)  18/94 (19.15%)  8/40 (20.00%) 
Memory impairment  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Neuropathy: motor  1  5/96 (5.21%)  8/94 (8.51%)  4/40 (10.00%) 
Neuropathy: sensory  1  49/96 (51.04%)  32/94 (34.04%)  9/40 (22.50%) 
Ocular/Visual-Other (Specify)  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Pain - Head/headache  1  13/96 (13.54%)  12/94 (12.77%)  5/40 (12.50%) 
Taste alteration (dysgeusia)  1  26/96 (27.08%)  15/94 (15.96%)  5/40 (12.50%) 
Tremor  1  10/96 (10.42%)  10/94 (10.64%)  2/40 (5.00%) 
Psychiatric disorders       
Confusion  1  7/96 (7.29%)  8/94 (8.51%)  2/40 (5.00%) 
Insomnia  1  34/96 (35.42%)  49/94 (52.13%)  8/40 (20.00%) 
Mood alteration - agitation  1  7/96 (7.29%)  9/94 (9.57%)  2/40 (5.00%) 
Mood alteration - anxiety  1  10/96 (10.42%)  9/94 (9.57%)  0/40 (0.00%) 
Mood alteration - depression  1  30/96 (31.25%)  23/94 (24.47%)  9/40 (22.50%) 
Renal and urinary disorders       
Incontinence, urinary  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Pain - Bladder  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Proteinuria  1  0/96 (0.00%)  0/94 (0.00%)  3/40 (7.50%) 
Urinary frequency/urgency  1  0/96 (0.00%)  7/94 (7.45%)  0/40 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  15/96 (15.63%)  15/94 (15.96%)  5/40 (12.50%) 
Dyspnea (shortness of breath)  1  19/96 (19.79%)  18/94 (19.15%)  0/40 (0.00%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  0/96 (0.00%)  5/94 (5.32%)  2/40 (5.00%) 
Skin and subcutaneous tissue disorders       
Dermatology/Skin-Other (Specify)  1  5/96 (5.21%)  11/94 (11.70%)  2/40 (5.00%) 
Dry skin  1  7/96 (7.29%)  0/94 (0.00%)  0/40 (0.00%) 
Hair loss/Alopecia (scalp or body)  1  6/96 (6.25%)  5/94 (5.32%)  0/40 (0.00%) 
Photosensitivity  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Rash/desquamation  1  22/96 (22.92%)  17/94 (18.09%)  11/40 (27.50%) 
Rash: acne/acneiform  1  0/96 (0.00%)  0/94 (0.00%)  4/40 (10.00%) 
Sweating (diaphoresis)  1  10/96 (10.42%)  13/94 (13.83%)  2/40 (5.00%) 
Ulceration  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Vascular disorders       
Flushing  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Hot flashes/flushes  1  0/96 (0.00%)  0/94 (0.00%)  2/40 (5.00%) 
Hypertension  1  9/96 (9.38%)  8/94 (8.51%)  2/40 (5.00%) 
Hypotension  1  12/96 (12.50%)  5/94 (5.32%)  0/40 (0.00%) 
Thrombosis/thrombus/embolism  1  10/96 (10.42%)  0/94 (0.00%)  6/40 (15.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Publications of Results:
Zonder JA, Crowley JJ, Bolejack V, et al.: A randomized Southwest Oncology Group study comparing dexamethasone (D) to lenalidomide + dexamethasone (LD) as treatment of newly-diagnosed multiple myeloma (NDMM): impact of cytogenetic abnormalities on efficacy of LD, and updated overall study results. [Abstract] J Clin Oncol 26 (Suppl 15): A-8521, 2008.
Zonder JA, Crowley J, Hussein MA, et al.: Superiority of lenalidomide (Len) plus high-dose dexamethasone (HD) compared to HD alone as treatment of newly-diagnosed multiple myeloma (NDMM): results of the randomized, double-blinded, placebo-controlled SWOG trial S0232. [Abstract] Blood 110 (11): A-77, 2007.
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00064038     History of Changes
Other Study ID Numbers: S0232
U10CA032102 ( U.S. NIH Grant/Contract )
S0232 ( Other Identifier: SWOG )
First Submitted: July 8, 2003
First Posted: July 9, 2003
Results First Submitted: November 19, 2012
Results First Posted: July 17, 2013
Last Update Posted: March 25, 2015