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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00064038
First received: July 8, 2003
Last updated: July 16, 2013
Last verified: July 2013
Results First Received: November 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Multiple Myeloma
Plasma Cell Neoplasm
Interventions: Drug: dexamethasone
Drug: lenalidomide
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between October 15, 2004 and April 2, 2007, 198 patients were enrolled at 41 cooperative medical institutions.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None.

Reporting Groups
  Description
Lenalidomide+Dexamethasone 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.
Dexamethasone 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.
Crossover to Lenalidomide+Dexamethasone

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.


Participant Flow for 2 periods

Period 1:   Initial Randomization
    Lenalidomide+Dexamethasone     Dexamethasone     Crossover to Lenalidomide+Dexamethasone  
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 2:   Crossover to Lenalidomide+Dexamethasone
    Lenalidomide+Dexamethasone     Dexamethasone     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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lenalidomide+Dexamethasone 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.
Dexamethasone 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 Total of all reporting groups

Baseline Measures
    Lenalidomide+Dexamethasone     Dexamethasone     Total  
Number of Participants  
[units: participants]
  97     95     192  
Age  
[units: years]
Median ( Full Range )
     
Overall     64.9  
  ( 36.9 to 89.0 )  
  63.1  
  ( 37.6 to 87.0 )  
  64.6  
  ( 36.9 to 89.0 )  
Gender  
[units: participants]
     
Female     44     40     84  
Male     53     55     108  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival   [ 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 ]

2.  Secondary:   Toxicity   [ 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: rorlowsk@mdanderson.org


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.

Publications automatically indexed to this study:

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00064038     History of Changes
Other Study ID Numbers: CDR0000306449, U10CA032102, S0232
Study First Received: July 8, 2003
Results First Received: November 19, 2012
Last Updated: July 16, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration