Pegylated Liposomal Doxorubicin, Low Freq Dexamethasone & Revlimid (Dd-R) in Newly Diagnosed Multiple Myeloma (MM)

This study has been completed.
Sponsor:
Collaborators:
Celgene Corporation
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00617591
First received: February 5, 2008
Last updated: December 16, 2013
Last verified: October 2013
Results First Received: October 25, 2013  
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: Lenalidomide
Drug: Pegylated Liposomal Doxorubicin (PLD)
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
57 Eligible participants were enrolled at Moffitt Cancer Center between February 2008 and February 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
Induction and Maintenance Therapy

Induction Phase Followed by Maintenance Therapy.

Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.

At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.

Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.


Participant Flow:   Overall Study
    Induction and Maintenance Therapy  
STARTED     57  
COMPLETED     47  
NOT COMPLETED     10  
Withdrew consent during Induction                 4  
Withdrew consent during Maintenance                 6  



  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.
All participants

Reporting Groups
  Description
Induction and Maintenance Therapy

Induction Phase Followed by Maintenance Therapy.

Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.

At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.

Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.


Baseline Measures
    Induction and Maintenance Therapy  
Number of Participants  
[units: participants]
  57  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     37  
>=65 years     20  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 36 to 78 )  
Gender  
[units: participants]
 
Female     26  
Male     31  
Region of Enrollment  
[units: participants]
 
United States     57  



  Outcome Measures
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1.  Primary:   Overall Response Rate (ORR) - Percentage of Participants With Partial Response or Better With Induction Regimen   [ Time Frame: 24 Months ]

2.  Primary:   Percentage of Participants With Very Good Partial Remission (VGPR) or Better   [ Time Frame: 24 Months ]

3.  Secondary:   Median Progression Free Survival (PFS) in Months   [ Time Frame: 24 Months ]

4.  Secondary:   2 Year Overall Survival (OS) Rate   [ Time Frame: 24 Months ]

5.  Secondary:   Occurrence of Induction Toxicities   [ Time Frame: 24 Months ]


  Serious Adverse Events


  Other Adverse Events


  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: Rachid Baz, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-8212
e-mail: rachid.baz@moffitt.org


No publications provided by H. Lee Moffitt Cancer Center and Research Institute

Publications automatically indexed to this study:

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00617591     History of Changes
Other Study ID Numbers: MCC-14986, 106095d, RV-MM-PI-107, 07OBCA990185
Study First Received: February 5, 2008
Results First Received: October 25, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration