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
18 Years
N/A
Both
Multiple Myeloma
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome 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).
Outcome Time Frame:
Phase 1
Safety Issue:
Yes
Principal Investigator
Moshe Talpaz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Michigan Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
UMCC 2007.098
NCT ID:
NCT00724568
Start Date:
May 2008
Completion Date:
January 2017
Related Keywords:
- Multiple Myeloma
- Newly Diagnosed Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| The University of Chicago Medical Center | Chicago, Illinois 60637-1470 |
| The Ohio State University Medical Center | Columbus, Ohio 43210 |
| Emory University Hospital | Atlanta, Georgia 30322 |
| Dana Farber Cancer Institute (and Massachusetts General) | Boston, Massachusetts 02115 |
