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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 : Active, not recruiting
First Posted : October 15, 2012
Results First Posted : June 3, 2016
Last Update Posted : September 26, 2017
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

  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
Arm A Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
Arm B 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.
Arm C Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.

Participant Flow:   Overall Study
    Arm A   Arm B   Arm C
STARTED   1   1   1 
COMPLETED   1   1   1 
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
Arm A Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
Arm B 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.
Arm C Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
Total Total of all reporting groups

Baseline Measures
   Arm A   Arm B   Arm C   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   1   1   3 
Age 
[Units: Years]
Median (Full Range)
 54   45   50   50 
 (45 to 54) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
       
United States   1   1   1   3 
Had Prior Treatment 
[Units: Participants]
 1   1   1   3 


  Outcome Measures

1.  Primary:   Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months   [ Time Frame: 24 months ]

2.  Secondary:   Survival Time   [ Time Frame: From registration to death due to any cause, assessed up to 3 years ]

3.  Secondary:   Progression-free Survival   [ Time Frame: From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years ]


  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:  
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
e-mail: Reeder.Craig@mayo.edu



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 26, 2017