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Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)

This study has been completed.
Sponsor:
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
National Marrow Donor Program
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00075829
First received: January 9, 2004
Last updated: August 3, 2016
Last verified: August 2016
Results First Received: December 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Procedure: One Autologous Transplant
Procedure: Non-Myeloablative Allogeneic Transplant
Procedure: Second Autologous Transplant
Drug: Thalidomide
Drug: Dexamethasone
Behavioral: Observation

  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
Participants were enrolled between December 2003 and March 2007 from 37 different transplant centers.

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
Auto-Auto Standard Risk Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.
Auto-Allo Standard Risk Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
Auto-Auto High Risk

Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients

PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.

Auto-Allo High Risk Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients

Participant Flow:   Overall Study
    Auto-Auto Standard Risk   Auto-Allo Standard Risk   Auto-Auto High Risk   Auto-Allo High Risk
STARTED   436   189   48   37 
COMPLETED   178 [1]   71 [1]   14 [1]   13 [1] 
NOT COMPLETED   258   118   34   24 
[1] Participants that were alive and free of disease progression at the end of follow-up (3 years)



  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.
Analysis is based on intention-to-treat data. Primary analysis of the clinical trial focused on patients meeting protocol criteria of standard risk multiple myeloma.

Reporting Groups
  Description
Auto-Auto Standard Risk

Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients

PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.

Auto-Allo Standard Risk Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
Auto-Auto High Risk

Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients

PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.

Auto-Allo High Risk Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
Total Total of all reporting groups

Baseline Measures
   Auto-Auto Standard Risk   Auto-Allo Standard Risk   Auto-Auto High Risk   Auto-Allo High Risk   Total 
Overall Participants Analyzed 
[Units: Participants]
 436   189   48   37   710 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 55 
 (22 to 70) 
 53 
 (29 to 68) 
 57 
 (32 to 70) 
 51 
 (32 to 66) 
 53.2 
 (22 to 68) 
Gender 
[Units: Participants]
         
Female   176   78   21   16   291 
Male   260   111   27   21   419 
Race/Ethnicity, Customized 
[Units: Participants]
         
African American   77   18   8   3   106 
Caucasian   335   161   38   33   567 
Other   24   10   2   1   37 
Karnofsky Performance score [1] 
[Units: Participants]
         
100 - 90   344   148   27   26   545 
< 90   92   41   21   11   165 
[1] Assesses patient self-perceived global quality of life and functioning (excellent, very good, good, fair, poor), where 100 equals perfect quality of life.
β-2 Microglobulin 
[Units: mg/L]
Median (Full Range)
 2.0 
 (0.004 to 4.0) 
 2.0 
 (0.9 to 4.0) 
 4.4 
 (0.9 to 9.8) 
 3.7 
 (1.2 to 6.6) 
 3.025 
 (0.004 to 9.8) 
Durie-Salmon [1] 
[Units: Participants]
         
Stages I-II   142   59   10   9   220 
Stage III   294   130   38   28   490 
[1] The Durie and Salmon classification uses three multiple myeloma stages. Stage I has all of the following: Hemoglobin greater than 10 g/dL, Serum calcium less than 12 mg/dL, Normal bone structure or solitary plasmacytoma on radiographs, and Low M component. Stage II does not fit either Stage I or Stage III. Stage III has one or more of the following: Hemoglobin less than 8.5 g/dL, Serum calcium greater than 12 mg/dL, Advanced lytic bone lesions, and/or Hyper M component.
Interval from diagnosis to transplantation 
[Units: Months]
Median (Full Range)
 7 
 (3 to 55) 
 7 
 (4 to 35) 
 7 
 (5 to 22) 
 7 
 (3 to 38) 
 7 
 (3 to 55) 
Disease status [1] 
[Units: Participants]
         
CR   41   24   1   3   69 
Near CR   65   22   1   2   90 
Very Good PR   79   32   1   7   119 
PR   158   76   21   14   269 
MR   31   17   10   3   61 
SD   21   6   6   4   37 
Not Evaluable   30   12   8   4   54 
Unknown   11   0   0   0   11 
[1] Disease status at time of first autologous transplantation represents the results from initial multiple myeloma therapy received prior to trial enrollment: Complete Response (CR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD)


  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Year 3 ]

2.  Secondary:   Overall Survival (OS) for Standard Risk   [ Time Frame: Years 1, 2, and 3 ]

3.  Secondary:   Overall Survival (OS) for High Risk   [ Time Frame: Year 3 ]

4.  Secondary:   Cumulative Incidence of Progression/Relapse   [ Time Frame: Year 3 ]

5.  Secondary:   Cumulative Incidence of Treatment Related Mortality (TRM)   [ Time Frame: Year 3 ]

6.  Secondary:   Interval From First to Second Transplantation   [ Time Frame: Year 1 ]

7.  Secondary:   Incidences of Graft Versus Host Disease (GVHD)   [ Time Frame: Day 100 ]

8.  Secondary:   Incidences of Chronic GVHD   [ Time Frame: Years 1 and 2 ]


  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: Adam Mendizabal
Organization: The EMMES Corporation
phone: 301-251-1161
e-mail: amendizabal@EMMES.com


Publications of Results:

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00075829     History of Changes
Obsolete Identifiers: NCT00321607, NCT00386568
Other Study ID Numbers: BMTCTN0102
BMT CTN 0102 ( Other Identifier: Blood and Marrow Transplant Clinicial Trials Network )
SUMC-79730 ( Other Identifier: Institutional Review Board at SUMC )
417 ( Other Identifier: NHLBI )
Study First Received: January 9, 2004
Results First Received: December 17, 2014
Last Updated: August 3, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board