Status:
COMPLETED
Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This research study is evaluating an investigational combination of four drugs called Revlimid® (lenalidomide), Velcade® (bortezomib), Dexamethasone and Doxil® (RVDD) as a possible treatment for newly...
Detailed Description
During the Phase I portion of this clinical trial, the doses of Revlimid® and Doxil® will be increased until the best and safest amount (or dose) is identified in combination with Velcade® and Dexamet...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- At least 18 years of age at the time of consent
- Measurable disease
- All necessary baseline studies completed
- LVEF (left ventricular ejection fraction) greater than or equal to 50 percent by MUGA (multigated acquisition scan) or ECHO (echocardiogram)
- Must be able to adhere to study visit schedule
- Exclusion
- Greater than or equal to grade 2 peripheral neuropathy on clinical examination within 14 days of enrollment
- Renal insufficiency
- Evidence of mucosal or internal bleeding and/ or platelet refractory.
- Absolute neutrophil count less than 1000 cells/mm\^2 within 14 days of enrollment.
- Acceptable labs
- Concomitant medications that include corticosteroids
- Myocardial infarction within 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias
- Clinically relevant active infection or serious medical condition that places the subject at unacceptable risk
- Any condition, including laboratory values that places the subject at an unacceptable risk
- Another malignancy within 3 years of enrollment, with the exception of the complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
- Hypersensitivity to bortezomib, boron, or mannitol or any of the components of DOXIL
- Female subject that is pregnant or breastfeeding.
- Can not have received any other investigational drugs within 14 days of enrollment
- Serious medical or psychiatric illness
- Uncontrolled diabetes mellitus
- Hypersensitivity to acyclovir or similar antiviral drug
- POEMS (plasma cell dyscrasia with polyneuropathy)
- Known HIV
- Known hepatitis B or C
- Known intolerance to steroid therapy
- Known hypersensitivity to required prophylactic mediations
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2014
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00724568
Start Date
May 1 2008
End Date
September 3 2014
Last Update
June 2 2017
Active Locations (6)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322
2
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
3
Dana Farber Cancer Institute (and Massachusetts General)
Boston, Massachusetts, United States, 02115
4
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109