Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatment lenalidomide, bortezomib, dexamethasone, doxil
Phase phase 1/phase 2
Sponsor Moshe Talpaz, M.D.
Start date May 2008
End date January 2017
Trial size 78 participants
Trial identifier NCT00724568, HUM 12962, UMCC 2007.098

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 diagnosed multiple myeloma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles. To determine the MTD of the combination of Revlimid, Velcade, dexamethasone, and Doxil, four dose levels are planned.
lenalidomide, bortezomib, dexamethasone, doxil Revlimid
Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles. To determine the MTD of the combination of Revlimid, Velcade, dexamethasone, and Doxil, four dose levels are planned.

Primary Outcomes

Measure
Determine the maximum tolerated dose (MTD) of combination therapy with Revlimid, VELCADE, Dexamethasone, and Doxil, (RVDD) and to evaluate the very good partial response rate (CR/nCR+VGPR).
time frame: Phase 1

Secondary Outcomes

Measure
The Phase II portion of the clinical trial will test the clinical effectiveness of the best dose combination of the four drugs
time frame: Phase II

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - You will be eligible to participate in this study if you are at least 18 years old and have newly diagnosed multiple myeloma. - You will have blood tests and other screening tests before you are enrolled and your test results must be within the limits outlined for eligibility to participate in this experimental study. Exclusion Criteria: - Chronic obstructive or chronic restrictive pulmonary disease and cirrhosis. - Patient has hypersensitivity to bortezomib, boron or mannitol or any of the components of DOXIL. - Female subject is pregnant or breast-feeding. - Patient has received other investigational drugs with 14 days before - Uncontrolled diabetes mellitus. - Hypersensitivity to acyclovir or similar anti-viral drug. - Known HIV infection. - Known active hepatitis B or C viral infection. - Known intolerance to steroid therapy. - Known hypersensitivity to required prophylactic medications.

Additional Information

Official title A Multi-Institutional Phase I/II Study of Revlimid® (Lenalidomide), Velcade® (Bortezomib), Dexamethasone, and Doxil®, (RVDD) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
Principal investigator Moshe Talpaz, MD
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 Dexamethasone. "Investigational" means that the drug combination is still being studied and that research doctors are trying to find out more about it such as the safest dose to use, the side effects it may cause and how effective the Velcade®, Doxil®, Dexamethasone and Revlimid® investigational combination is for treating newly diagnosed multiple myeloma. In this clinical trial we are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients. Each of these drugs, Velcade®, Doxil®, Dexamethasone and Revlimid® are approved by the FDA (U.S. Food and Drug Administration). They have not been approved in this combination for use for your type of cancer or any other type of cancer. Velcade® is currently approved by the United States Food and Drug Administration (US FDA) for the treatment of multiple myeloma patients who have received at least one prior therapy. Doxil® has recently been approved by the US FDA for multiple myeloma in combination with Velcade® in patients who have not previously received Velcade® and have received at least one prior therapy. Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma. Revlimid® is currently approved by the US FDA in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. After the Phase I clinical trial defines the safest doses of Velcade®, Doxil®, Dexamethasone and Revlimid® that can be taken together, the research study will move on to its second portion, a Phase II clinical trial. The Phase II portion of the clinical trial will test the clinical effectiveness of the best dose combination of the four drugs.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.