Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation

This study has been terminated.
(Due to the high rate of morbidity and mortality)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01653418
First received: July 23, 2012
Last updated: October 8, 2014
Last verified: October 2014
Results First Received: September 26, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Bortezomib
Drug: Carmustine
Drug: Etoposide
Drug: Cytarabine
Drug: Melphalan
Procedure: Stem cell infusion

  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 opened to participant enrollment on 09/20/2012 and closed to participant enrollment on 06/18/2013.

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
V-BEAM + Stem Cell Infusion Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0

Participant Flow:   Overall Study
    V-BEAM + Stem Cell Infusion  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     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
V-BEAM + Stem Cell Infusion Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0

Baseline Measures
    V-BEAM + Stem Cell Infusion  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Median ( Full Range )
  64.5  
  ( 48 to 69 )  
Gender  
[units: participants]
 
Female     5  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     10  
Study-Specific Measure [1]
[units: participants]
 
Stage I     0  
Stage IIA     3  
Stage IIIA     7  
Study-Specific Measure [2]
[units: participants]
 
Stage I     2  
Stage II     5  
Stage III     2  
Unknown     1  
Study-Specific Measure [3]
[units: participants]
 
IgG     3  
IgA     5  
Light chain only     2  
Study-Specific Measure  
[units: months]
Median ( Full Range )
  29  
  ( 17 to 97 )  
Study-Specific Measure  
[units: months]
Median ( Full Range )
  42  
  ( 27 to 118 )  
Study-Specific Measure  
[units: prior┬átherapies]
Median ( Full Range )
  4  
  ( 3 to 6 )  
[1]

STAGE I

  • Hemoglobin >10g/dL
  • Serum calcium normal or <10.5mg/dL
  • Bone x-ray, normal bone structure (scale 0), or solitary bone plasmacytoma only
  • Low M-component production rates IgG value <5g/dL; IgA value <3g/dL
  • Urine light chain M-component on electrophoresis <4g/24h

STAGE II -Neither Stage I or Stage III

STAGE III

  • Hemoglobin <8.5g/dL
  • Serum calcium >12mg/dL
  • Advanced lytic bone lesions (scale 3) -High M-component production rates IgG value >7g/dL IgA value >5g/dL- Bence Jones protein >12g/24h

SUBCLASS

-A: relatively normal renal function (serum creatinine) <2.0 mg/dL

[2]

STAGE I

-Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L)

STAGE II -Neither stage I or III

STAGE III

-Serum beta-2 microglobulin is greater than 5.5

[3]

Antibodies typically consist of 2 heavy chains and 2 light chains. There are 5 kinds of heavy chains termed IgG, IgA, IgM, IgD, and IgE; and 2 distinct types of light chain, termed kappa and lambda. In myeloma, all the abnormal plasma cells make the same antibody. Therefore the myeloma can be classified by the type of light and heavy chains produced, such as IgG kappa, IgG lambda, IgA kappa, or IgA lambda, etc.

Occasionally, the malignant plasma cells make only the light chain component of the antibody. These patients are said to have “light chain myeloma.”




  Outcome Measures
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1.  Primary:   Complete Response Rate (Complete Response + Stringent Complete Response)   [ Time Frame: Day +100 ]

2.  Secondary:   Number of Participants With Progression-free Survival (PFS)   [ Time Frame: Median follow-up of 6 months (range: 6.0-12.0 months) ]

3.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: 3 months following Day +100 visit ]

4.  Secondary:   Very Good Partial Response Rate (VGPR+nCR+sCR+CR)   [ Time Frame: Day +100 ]

5.  Secondary:   Toxicity of V-BEAM   [ Time Frame: 30 days after end of treatment / Day +100 ]

6.  Secondary:   Time to Neutrophil Engraftment After V-BEAM.   [ Time Frame: Day +100 ]

7.  Secondary:   Number of Participants With Overall Survival (OS)   [ Time Frame: Median follow-up of 6 months (range: 6-12 months) ]

8.  Secondary:   Treatment Related Mortality (TRM) of V-BEAM   [ Time Frame: Day +100 ]

9.  Secondary:   Time to Platelet Engraftment After V-BEAM.   [ Time Frame: Day +100 ]


  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
2 early deaths caused a concern for safety and resulted in suspension of enrollment in May 2013. After a review of the data, the investigators determined that this regimen had unexpected toxicity & the trial was closed to enrollment in June 2013.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ravi Vij, M.D.
Organization: Washington University School of Medicine
phone: 314-454-8304
e-mail: rvij@dom.wustl.edu


No publications provided


Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01653418     History of Changes
Other Study ID Numbers: 201208046
Study First Received: July 23, 2012
Results First Received: September 26, 2014
Last Updated: October 8, 2014
Health Authority: United States: Institutional Review Board