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Cyclophosphamide, VELCADE, DOXIL, and Dexamethasone, (CVDD) in Newly Diagnosed Patients With Multiple Myeloma (MM)

This study has been completed.
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Ortho Biotech, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00750815
First received: September 10, 2008
Last updated: December 3, 2013
Last verified: September 2013
Results First Received: September 23, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Cyclophosphamide
Drug: Bortezomib; Pegylated Liposomal Doxorubicin; Dexamethasone (VDD)

  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 recruited at Moffitt Cancer Center from September 2008 to August 2011.

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
A. Phase I - Dose Escalation

Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:

  • Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
  • Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
  • Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
  • Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
B. Phase II - Maximum Planned Dose (MPD) Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.

Participant Flow:   Overall Study
    A. Phase I - Dose Escalation     B. Phase II - Maximum Planned Dose (MPD)  
STARTED     12     46  
COMPLETED     12     46  
NOT COMPLETED     0     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.
Overall Survival by disease risk stratification: 54 participants with cytogenetics and fluorescence in situ hybridisation (FISH) results available for risk stratification. All other measures: 58 Participants.

Reporting Groups
  Description
A. Phase I - Dose Escalation

Dose of Cyclophosphamide depended on how many patients we had treated:

  • Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
  • Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
  • Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
  • Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
B. Phase II - Maximum Planned Dose (MPD) Participants received Cyclophosphamide and VELCADE at the MPD at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
Total Total of all reporting groups

Baseline Measures
    A. Phase I - Dose Escalation     B. Phase II - Maximum Planned Dose (MPD)     Total  
Number of Participants  
[units: participants]
  12     46     58  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     34     42  
>=65 years     4     12     16  
Age  
[units: years]
Mean ( Full Range )
  58.75  
  ( 46 to 77 )  
  57  
  ( 25 to 75 )  
  57  
  ( 25 to 77 )  
Gender  
[units: participants]
     
Female     4     20     24  
Male     8     26     34  
Region of Enrollment  
[units: participants]
     
United States     12     46     58  



  Outcome Measures
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1.  Primary:   Phase I - Maximum Planned Dose (MPD) Level   [ Time Frame: 9 months ]

2.  Primary:   Phase II: Overall Response Rate (ORR)   [ Time Frame: Up to 6 months ]

3.  Secondary:   Phase II: Progression-Free Survival (PFS)   [ Time Frame: Up to 50.9 months ]

4.  Secondary:   Phase II: Two Year Overall Survival (OS)   [ Time Frame: 2 years ]


  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
Trial closed early after 58 patients were enrolled due to slow accrual and shortage of pegylated liposomal doxorubicin. Only 54 participants had cytogenetics and fluorescence in situ hybridisation (FISH) results available for risk stratification.


  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: Melissa Alsina, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-6886
e-mail: melissa.alsina@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00750815     History of Changes
Other Study ID Numbers: MCC-15399, 106692, Millennium X05248, DOXILMMY2008
Study First Received: September 10, 2008
Results First Received: September 23, 2013
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board