Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00602641
First received: January 18, 2008
Last updated: June 9, 2015
Last verified: March 2015
Results First Received: May 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Interventions: Drug: melphalan
Drug: prednisone
Drug: thalidomide
Drug: lenalidomide

  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
The study was activated on February 29, 2008 and closed to accrual on November 30, 2011 with final accrual of 306 patients.

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 (MPT-T)

Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).

INDUCTION THERAPY: Patients receive melphalan 9 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and thalidomide 100 mg PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive thalidomide 100 mg PO daily and continue in the absence of disease progression.

Arm II (mPR-R)

Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).

INDUCTION THERAPY: Patients receive melphalan 5 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and lenalidomide 10 mg PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive lenalidomide 10 mg PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.


Participant Flow:   Overall Study
    Arm I (MPT-T)     Arm II (mPR-R)  
STARTED     154     152  
Started Protocol Therapy     148     150  
COMPLETED     0 [1]   0 [1]
NOT COMPLETED     154     152  
Never started protocol therapy                 6                 2  
Still on treatment at time of analysis                 8                 15  
Adverse Event                 62                 53  
Disease progression                 38                 55  
Death                 6                 5  
Withdrawal by Subject                 15                 12  
Alternative therapy                 5                 2  
Other Complicating Disease                 5                 2  
Physician Decision                 5                 4  
Administrative Closure                 1                 1  
Unknown                 3                 1  
[1] Treatment continued until progression of disease, unacceptable toxicity or patient withdrawal.



  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
Arm I (MPT-T)

Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).

INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.

melphalan: Given PO

prednisone: Given PO

thalidomide: Given PO

Arm II (mPR-R)

Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).

INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.

melphalan: Given PO

prednisone: Given PO

lenalidomide: Given PO

Total Total of all reporting groups

Baseline Measures
    Arm I (MPT-T)     Arm II (mPR-R)     Total  
Number of Participants  
[units: participants]
  154     152     306  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     6     15  
>=65 years     145     146     291  
Gender  
[units: participants]
     
Female     68     71     139  
Male     86     81     167  
International Staging System (ISS) [1]
[units: participants]
     
Stage I     45     36     81  
Stage II     58     70     128  
Stage III     49     46     95  
Unknown/Missing     2     0     2  
[1]

The staging criteria for International Staging System:

Stage I: Serum β2 microglobulin <3.5 mg/L, Serum albumin ≥ 3.5 g/dL Stage II: Not I or III Stage III: Serum β2 microglobulin >5.5 mg/L




  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. ]

2.  Secondary:   Overall Survival   [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. ]

3.  Secondary:   Very Good Partial Response (VGPR) Rate   [ Time Frame: Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry. ]

4.  Secondary:   Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12   [ Time Frame: Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit. ]


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


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00602641     History of Changes
Other Study ID Numbers: NCI-2009-00522, E1A06, U10CA021115
Study First Received: January 18, 2008
Results First Received: May 5, 2015
Last Updated: June 9, 2015
Health Authority: United States: Federal Government