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Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Michaela Liedtke, Stanford University
ClinicalTrials.gov Identifier:
NCT01355705
First received: May 16, 2011
Last updated: January 11, 2017
Last verified: January 2017
Results First Received: January 11, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Amrubicin
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Aspirin
Drug: Pegfilgrastim

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Amrubicin + Lenalidomide + Dexamethasone

Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.

Concurrent therapeutic medications:

  • Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
  • Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)

Other drugs:

  • Aspirin: 81 or 325 mg daily oral
  • Pegfilgrastim subcutaneous on Day 2

Participant Flow:   Overall Study
    Amrubicin + Lenalidomide + Dexamethasone
STARTED   14 
COMPLETED [1]   14 
NOT COMPLETED   0 
[1] 1 subject completed but was not evaluable.



  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.
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Reporting Groups
  Description
Amrubicin + Lenalidomide + Dexamethasone

Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.

Concurrent therapeutic medications:

  • Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
  • Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)

Other drugs:

  • Aspirin: 81 or 325 mg daily oral
  • Pegfilgrastim subcutaneous on Day 2

Baseline Measures
   Amrubicin + Lenalidomide + Dexamethasone 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8  57.1% 
>=65 years      6  42.9% 
Gender 
[Units: Participants]
Count of Participants
 
Female      5  35.7% 
Male      9  64.3% 
Region of Enrollment 
[Units: Participants]
 
United States   14 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rates After Amrubicin + Lenalidomide + Dexamethasone to Treat Relapsed / Refractory Multiple Myeloma   [ Time Frame: 12 weeks ]

2.  Secondary:   Duration of Response (DOR)   [ Time Frame: 140 days ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: 9 months ]

4.  Secondary:   Time-to-next Treatment   [ Time Frame: 9 months ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michaela Liedtke, MD
Organization: Stanford University
phone: 650-498-6000
e-mail: mliedtke@stanford.edu



Responsible Party: Michaela Liedtke, Stanford University
ClinicalTrials.gov Identifier: NCT01355705     History of Changes
Other Study ID Numbers: IRB-19092
AR_MM_PI_007 ( Other Identifier: Celgene Corporation )
SU-05062011-7711 ( Other Identifier: Stanford University )
HEMMYL0018 ( Other Identifier: OnCore )
Study First Received: May 16, 2011
Results First Received: January 11, 2017
Last Updated: January 11, 2017