Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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 diagnosed multiple myeloma.

Key facts

Study ID

NCT00724568

Run by

University of Michigan Rogel Cancer Center

People needed

74

Starts

2008-05-01

Expected to finish

2014-09-03

Last updated by the study team

2017-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Dana Farber Cancer Institute (and Massachusetts General) — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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