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Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)

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ClinicalTrials.gov Identifier: NCT01109004
Recruitment Status : Active, not recruiting
First Posted : April 22, 2010
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Lenalidomide
Drug: lenalidomide, bortezomib and dexamethasone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Tandem Auto Transplant

Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance

Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

RVD Consolidation

Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance

lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Lenalidomide Maintenance

Initial autologous transplant followed by lenalidomide maintenance

Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.


Participant Flow:   Overall Study
    Tandem Auto Transplant   RVD Consolidation   Lenalidomide Maintenance
STARTED   247   254   257 
COMPLETED   247   254   257 
NOT COMPLETED   0   0   0 



  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
Tandem Auto Transplant

Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance

Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

RVD Consolidation

Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance

lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Lenalidomide Maintenance

Initial autologous transplant followed by lenalidomide maintenance

Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Total Total of all reporting groups

Baseline Measures
   Tandem Auto Transplant   RVD Consolidation   Lenalidomide Maintenance   Total 
Overall Participants Analyzed 
[Units: Participants]
 247   254   257   758 
Age 
[Units: Years]
Median (Full Range)
 56 
 (28 to 70) 
 57 
 (20 to 70) 
 56 
 (30 to 70) 
 56 
 (20 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      100  40.5%      108  42.5%      96  37.4%      304  40.1% 
Male      147  59.5%      146  57.5%      161  62.6%      454  59.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Caucasian      178  72.1%      192  75.6%      201  78.2%      571  75.3% 
African American      50  20.2%      39  15.4%      41  16.0%      130  17.2% 
Multiple/Other/Unknown      19   7.7%      23   9.1%      15   5.8%      57   7.5% 
Karnofsky Performance Score (KPS) [1] 
[Units: Participants]
Count of Participants
       
90 or Greater      182  73.7%      169  66.5%      172  66.9%      523  69.0% 
Less Than 90      65  26.3%      85  33.5%      85  33.1%      235  31.0% 
Disease Risk [1] 
[Units: Participants]
Count of Participants
       
Standard      175  70.9%      178  70.1%      182  70.8%      535  70.6% 
High      72  29.1%      76  29.9%      75  29.2%      223  29.4% 
Initial Therapy [1] 
[Units: Participants]
Count of Participants
       
Bortezomib/Lenalidomide/Dexamethasone      141  57.1%      136  53.5%      143  55.6%      420  55.4% 
Bortezomib/Cyclophosphamide/Dexamethasone      33  13.4%      35  13.8%      40  15.6%      108  14.2% 
Lenalidomide/Dexamethasone      24   9.7%      28  11.0%      22   8.6%      74   9.8% 
Bortezomib/Dexamethasone      29  11.7%      32  12.6%      32  12.5%      93  12.3% 
Other      19   7.7%      19   7.5%      20   7.8%      58   7.7% 
Unknown      1   0.4%      4   1.6%      0   0.0%      5   0.7% 
Time from Initial Therapy to Enrollment 
[Units: Months]
Median (Full Range)
 5 
 (2 to 14) 
 5 
 (2 to 12) 
 5 
 (2 to 12) 
 5 
 (2 to 14) 
Number of Lines of Therapy [1] 
[Units: Participants]
Count of Participants
       
    210  85.0%      213  83.9%      218  84.8%      641  84.6% 
    31  12.6%      36  14.2%      37  14.4%      104  13.7% 
    5   2.0%      1   0.4%      2   0.8%      8   1.1% 
Unknown      1   0.4%      4   1.6%      0   0.0%      5   0.7% 
Disease Status at Enrollment 
[Units: Participants]
Count of Participants
       
Stringent Complete Response      21   8.5%      26  10.2%      23   8.9%      70   9.2% 
Complete Response      22   8.9%      19   7.5%      24   9.3%      65   8.6% 
Near Complete Response      27  10.9%      22   8.7%      24   9.3%      73   9.6% 
Very Good Partial Response      52  21.1%      53  20.9%      43  16.7%      148  19.5% 
Partial Response      106  42.9%      108  42.5%      123  47.9%      337  44.5% 
Stable Disease      14   5.7%      21   8.3%      14   5.4%      49   6.5% 
Progression      4   1.6%      2   0.8%      3   1.2%      9   1.2% 
Not Evaluable      1   0.4%      3   1.2%      3   1.2%      7   0.9% 


  Outcome Measures

1.  Primary:   Percentage of Participants With Progression-free Survival (PFS)   [ Time Frame: 38 months post-randomization ]

2.  Secondary:   Response to Treatment   [ Time Frame: 1 and 2 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  

3.  Secondary:   Overall Survival (OS)   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  

4.  Secondary:   Incidence of Progression   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  

5.  Secondary:   Incidence of Toxicities   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  

6.  Secondary:   Incidence of Infections   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  

7.  Secondary:   Treatment Related Mortality   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  

8.  Secondary:   Non-compliance With Medication   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  

9.  Secondary:   Quality of Life   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  


  Serious Adverse Events


  Other Adverse Events


  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

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: Adam Mendizabal, PhD
Organization: The Emmes Corporation
e-mail: amendizabal@emmes.com



Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01109004     History of Changes
Obsolete Identifiers: NCT02257515
Other Study ID Numbers: BMTCTN0702
BMT CTN 0702 ( Other Identifier: Blood and Marrow Transplant Clinicial Trials Network )
U01HL069294-05 ( U.S. NIH Grant/Contract )
690 ( Other Identifier: National Heart, Lung, and Blood Institute )
First Submitted: April 21, 2010
First Posted: April 22, 2010
Results First Submitted: April 5, 2018
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018