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Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00114101
First received: June 13, 2005
Last updated: September 18, 2014
Last verified: June 2014
Results First Received: March 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Interventions: Drug: lenalidomide
Other: placebo
Procedure: peripheral blood stem cell transplantation
Drug: melphalan
Drug: cyclophosphamide
Biological: filgrastim

  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
From December 2004 and July 2009, a total of 568 participants were recruited to this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After registration, participants underwent a peripheral blood stem cell transplant. Of the 568 participants, 460 were randomized to either arm, stratified by beta2 microglobulin, prior thalidomide use and prior lenalidomide use. (108 participants dropped out prior to randomization, most common reasons include: progression, ineligible, refusal)

Reporting Groups
  Description
Lenalidomide Maintenance Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
Placebo Maintenance

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

(closed as of 12/17/09)


Participant Flow:   Overall Study
    Lenalidomide Maintenance     Placebo Maintenance  
STARTED     231     229  
COMPLETED     231     229  
NOT COMPLETED     0     0  



  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 Maintenance Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
Placebo Maintenance

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

(closed as of 12/17/09)

Total Total of all reporting groups

Baseline Measures
    Lenalidomide Maintenance     Placebo Maintenance     Total  
Number of Participants  
[units: participants]
  231     229     460  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 29 to 71 )  
  58  
  ( 40 to 71 )  
  59  
  ( 29 to 71 )  
Gender  
[units: participants]
     
Female     110     100     210  
Male     121     129     250  
Region of Enrollment  
[units: participants]
     
United States     231     229     460  
Beta 2 microglobulin at registration  
[units: participants]
     
> 2.5 mg/liter     50     55     105  
<= 2.5 mg/liter     170     163     333  
Missing data     11     11     22  
Prior use of thalidomide during induction  
[units: participants]
     
Yes     102     103     205  
No     129     126     255  
Prior use of lenalidomide during induction therapy  
[units: participants]
     
Yes     79     81     160  
No     152     148     300  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Progression   [ Time Frame: Duration of study (up to 10years) ]

2.  Secondary:   Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100   [ Time Frame: Day 100 ]

3.  Other Pre-specified:   Overall Survival   [ Time Frame: Duration of study (up to 10 years) ]

4.  Post-Hoc:   Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy   [ Time Frame: Duration of study (up to 10 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 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.
The agreement is:
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Philip McCarthy, MD
Organization: Roswell Park Cancer Institute
e-mail: philip.mccarthy@roswellpark.org


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00114101     History of Changes
Other Study ID Numbers: NCI-2009-00439, NCI-2009-00439, CDR0000434845, CALGB 100104/ECOG 100104, CALGB-100104, U10CA031946, P30CA014236
Study First Received: June 13, 2005
Results First Received: March 28, 2013
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration