Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098475
First received: December 7, 2004
Last updated: July 7, 2014
Last verified: July 2014
Results First Received: August 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Interventions: Drug: lenalidomide
Drug: dexamethasone
Drug: thalidomide
Other: laboratory biomarker analysis

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened on October 26, 2004 and was closed on June 1, 2007 with a total accrual of 452 patients enrolled from 6 groups and 77 institutions.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Lenalidomide, Dexamethasone) Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
Arm II (Lenalidomide, Low-dose Dexamethasone) Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin) Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin) Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.

Participant Flow for 2 periods

Period 1:   Step 1
    Arm I (Lenalidomide, Dexamethasone)     Arm II (Lenalidomide, Low-dose Dexamethasone)     Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)     Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)  
STARTED     223     222     4     3  
Treated     223     220     4     3  
Eligible     214 [1]   208 [1]   4     3  
COMPLETED     52     49     0     0  
NOT COMPLETED     171     173     4     3  
Progressive disease                 33                 35                 2                 1  
Adverse Event                 56                 37                 0                 1  
Death                 8                 5                 0                 1  
Withdrawal by Subject                 14                 11                 0                 0  
Physician Decision                 5                 2                 0                 0  
Alternative therapy                 31                 43                 1                 0  
Other disease                 2                 1                 1                 0  
Never started treatment                 0                 2                 0                 0  
Still on treatment as of this analysis                 14                 27                 0                 0  
Knee surgery                 1                 0                 0                 0  
Complications                 1                 0                 0                 0  
Cannot comply due to other tx                 0                 1                 0                 0  
Both patient and physician's decision                 2                 1                 0                 0  
Incorrect disease assessment                 2                 0                 0                 0  
Off treatment for > specified timeframe                 1                 1                 0                 0  
Declining performance status                 0                 1                 0                 0  
Insurance issue                 0                 1                 0                 0  
Rising paraprotein                 0                 1                 0                 0  
Referred to other physicians                 0                 1                 0                 0  
Criteria to continue treatment not met                 0                 1                 0                 0  
Misinterpretation of lab data                 0                 1                 0                 0  
Patient fell with fracture                 1                 0                 0                 0  
Not documented                 0                 1                 0                 0  
[1] Some patients were considered eligible at registration but found ineligible in the analysis.

Period 2:   Step 2
    Arm I (Lenalidomide, Dexamethasone)     Arm II (Lenalidomide, Low-dose Dexamethasone)     Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)     Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)  
STARTED     5 [1]   15 [1]   0     0  
Treated     4     14     0     0  
Eligible     2 [2]   9 [2]   0     0  
COMPLETED     0     5     0     0  
NOT COMPLETED     5     10     0     0  
Disease progression                 1                 4                 0                 0  
Adverse Event                 2                 0                 0                 0  
Withdrawal by Subject                 0                 2                 0                 0  
Physician Decision                 0                 1                 0                 0  
Alternative therapy                 1                 2                 0                 0  
Never started treatment                 1                 1                 0                 0  
[1] Step 2 treatment was an option but not required for patients who ended step 1 treatment.
[2] Some patients were considered eligible at registration but found ineligible in the analysis.



  Baseline Characteristics
  Hide Baseline Characteristics

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
Arm I (Lenalidomide, Dexamethasone)

Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.

As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.

Arm II (Lenalidomide, Low-dose Dexamethasone)

Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.

As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.

Total Total of all reporting groups

Baseline Measures
    Arm I (Lenalidomide, Dexamethasone)     Arm II (Lenalidomide, Low-dose Dexamethasone)     Total  
Number of Participants  
[units: participants]
  223     222     445  
Age  
[units: years]
Median ( Full Range )
  66  
  ( 36 to 87 )  
  65  
  ( 35 to 85 )  
  65  
  ( 35 to 87 )  
Gender  
[units: participants]
     
Female     91     101     192  
Male     132     121     253  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Patients With Objective Response (First Phase, Step 1)   [ Time Frame: Assessed every 4 weeks for 16 weeks during Step 1 ]

2.  Secondary:   Proportion of Patients With Objective Response (First Phase, Step 2)   [ Time Frame: Assessed every 4 weeks for 16 weeks during Step 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00098475     History of Changes
Other Study ID Numbers: NCI-2012-03150, NCI-2012-03150, CDR0000404161, E4A03, E4A03, U10CA021115, U10CA180820
Study First Received: December 7, 2004
Results First Received: August 30, 2013
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration