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Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00609167
First received: January 31, 2008
Last updated: May 13, 2011
Last verified: May 2011
History of Changes
Results First Received: November 5, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma and Plasma Cell Neoplasm
Interventions: Drug: bortezomib
Drug: cyclophosphamide
Drug: dexamethasone

  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
Sixty-three(63) participants were recruited between December 2006 and October 2008 at either Mayo Clinic Arizona or Princess Margaret Hospital.

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
CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Participant Flow:   Overall Study
    CyBorD (Bortezomib 1.3mg/m^2)     CyBorD (Bortezomib 1.5mg/m^2)  
STARTED     33     30  
COMPLETED     25     23  
NOT COMPLETED     8     7  
Withdrawal by Subject                 1                 0  
Lack of Efficacy                 1                 0  
Adverse Event                 5                 1  
Disease Progression                 1                 0  
Stem Cell Transplant                 0                 6  



  Baseline Characteristics
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Reporting Groups
  Description
CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22
Total Total of all reporting groups

Baseline Measures
    CyBorD (Bortezomib 1.3mg/m^2)     CyBorD (Bortezomib 1.5mg/m^2)     Total  
Number of Participants  
[units: participants]
 		  33     30     63  
Age  
[units: years]
Median ( Full Range ) 		  60  
  ( 38 to 75 )   		  61  
  ( 36 to 70 )   		  61  
  ( 36 to 75 )  
Gender  
[units: participants]
 		     
Female     16     14     30  
Male     17     16     33  
Region of Enrollment  
[units: participants]
 		     
United States     12     12     24  
Canada     21     18     39  
Parameters of Hematologic Response - Serum M-spike >=1g/dL  
[units: participants]
 		     
Yes     25     18     43  
No     8     12     20  
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >=10mg/dL  
[units: participants]
 		     
Yes     24     26     50  
No     9     4     13  
Parameter of Hematologic Response - Urine M-Spike >= 200mg/24 hours  
[units: participants]
 		     
Yes     16     11     27  
No     17     19     36  
Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30%  
[units: participants]
 		     
Yes     23     22     45  
No     10     8     18  



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment   [ Time Frame: After 4 months of treatment ]
  Show Outcome Measure 1

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: up to 5 years ]
  Show Outcome Measure 2

3.  Secondary:   Overall Survival (OS)   [ Time Frame: From date of registration until death (up to 5 years) ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Overall Survival (OS)
Measure Description OS was defined as the time from registration to death of any cause.
Time Frame From date of registration until death (up to 5 years)  
Safety Issue No  

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
CyBorD (Bortezomib 1.3mg/m^2)

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20
CyBorD (Bortezomib 1.5mg/m^2)

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Measured Values
    CyBorD (Bortezomib 1.3mg/m^2)     CyBorD (Bortezomib 1.5mg/m^2)  
Number of Participants Analyzed  
[units: participants]
 		  33     30  
Overall Survival (OS)  
[units: months]
Median ( 95% Confidence Interval ) 		  NA  
  ( NA to NA ) [1] 		  NA  
  ( NA to NA ) [2]
[1] Median OS for group 1 has not been attained.
[2] Median OS for group 2 has not been attained.

No statistical analysis provided for Overall Survival (OS)



4.  Secondary:   Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles   [ Time Frame: 4 cycles ]
  Show Outcome Measure 4

5.  Secondary:   Duration of Response   [ Time Frame: Duration of study (up to 12 cycles) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles   [ Time Frame: After 8 cycles of treatment ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles   [ Time Frame: After 12 cycles of treatment ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants With Severe Adverse Events   [ Time Frame: Every cycle during treatment (up to 12 cycles) ]
  Show Outcome Measure 8

9.  Secondary:   Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant   [ Time Frame: After 4 cycles of treatment ]
  Show Outcome Measure 9


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


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.  


Results Point of Contact:  
Name/Title: Dr. A. Keith Stewart
Organization: Mayo Clinic
e-mail: stewart.keith@mayo.edu


Publications of Results:


Responsible Party: Alexander Keith Stewart, M.B.Ch.B, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00609167     History of Changes
Other Study ID Numbers: CDR0000583225, P30CA015083, MC0686, 06-002613, NCI-2010-02147
Study First Received: January 31, 2008
Results First Received: November 5, 2010
Last Updated: May 13, 2011
Health Authority: United States: Federal Government