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Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT01706666
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : June 3, 2016
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Interventions Drug: bortezomib
Drug: cyclophosphamide
Drug: lenalidomide
Other: laboratory biomarker analysis
Drug: dexamethasone
Procedure: quality-of-life assessment
Enrollment 3

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
Period Title: Overall Study
Started 1 1 1
Completed 1 1 1
Not Completed 0 0 0
Arm/Group Title Arm A Arm B Arm C Total
Hide Arm/Group Description Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28. Total of all reporting groups
Overall Number of Baseline Participants 1 1 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 1 participants 3 participants
54 45 50
50
(45 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 3 participants
Female
0
   0.0%
1
 100.0%
1
 100.0%
2
  66.7%
Male
1
 100.0%
0
   0.0%
0
   0.0%
1
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 3 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
1
 100.0%
3
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
 100.0%
0
   0.0%
1
  33.3%
White
1
 100.0%
0
   0.0%
1
 100.0%
2
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 1 participants 3 participants
1 1 1 3
Had Prior Treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 3 participants
1 1 1 3
1.Primary Outcome
Title Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months
Hide Description Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:
Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
Overall Number of Participants Analyzed 1 1 1
Measure Type: Number
Unit of Measure: percentage of participants
100 0 100
2.Secondary Outcome
Title Survival Time
Hide Description The distribution of survival time will be estimated by arm using the method of Kaplan-Meier.
Time Frame From registration to death due to any cause, assessed up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients are still alive
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:
Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
Overall Number of Participants Analyzed 1 1 1
Measure Type: Number
Unit of Measure: Months to death
NA [1]  NA [1]  NA [1] 
[1]
No Deaths
3.Secondary Outcome
Title Progression-free Survival
Hide Description The distribution of progression-free survival will be estimated by arm using the method of Kaplan-Meier.
Time Frame From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description:
Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
Overall Number of Participants Analyzed 1 1 1
Measure Type: Number
Unit of Measure: Months to Progression
NA [1]  9.2 NA [1] 
[1]
No progressions
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
All-Cause Mortality
Arm A Arm B Arm C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B Arm C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/1 (0.00%)      1/1 (100.00%)    
Investigations       
Neutrophil count decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
Vascular disorders       
Hypertension  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A Arm B Arm C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders       
Anemia  1  1/1 (100.00%)  5 1/1 (100.00%)  10 0/1 (0.00%)  0
Gastrointestinal disorders       
Constipation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  10
Diarrhea  1  0/1 (0.00%)  0 1/1 (100.00%)  7 1/1 (100.00%)  2
Nausea  1  0/1 (0.00%)  0 1/1 (100.00%)  9 1/1 (100.00%)  2
Vomiting  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
General disorders       
Fatigue  1  1/1 (100.00%)  1 1/1 (100.00%)  6 1/1 (100.00%)  13
Injection site reaction  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0
Malaise  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Investigations       
Neutrophil count decreased  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  10
Platelet count decreased  1  1/1 (100.00%)  1 0/1 (0.00%)  0 1/1 (100.00%)  10
White blood cell decreased  1  0/1 (0.00%)  0 1/1 (100.00%)  5 1/1 (100.00%)  9
Nervous system disorders       
Peripheral sensory neuropathy  1  1/1 (100.00%)  1 0/1 (0.00%)  0 1/1 (100.00%)  1
Renal and urinary disorders       
Cystitis noninfective  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Craig B Reeder, MD
Organization: Mayo Clinic Cancer Center
Phone: 4803018335
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01706666     History of Changes
Other Study ID Numbers: MC1186
NCI-2012-01579 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: October 11, 2012
First Posted: October 15, 2012
Results First Submitted: April 27, 2016
Results First Posted: June 3, 2016
Last Update Posted: September 17, 2018