Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: lenalidomide, bortezomib, dexamethasone, doxil |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 78 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combination Drug Therapy
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.
|
Drug: lenalidomide, bortezomib, dexamethasone, doxil
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.
Other Names:
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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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Georgia | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| The University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute (and Massachusetts General) | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Ohio | |
| The Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: | Moshe Talpaz, MD | University of Michigan Cancer Center |
More Information
No publications provided by University of Michigan Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00724568 History of Changes |
| Other Study ID Numbers: | UMCC 2007.098, HUM 12962 |
| Study First Received: | April 11, 2008 |
| Last Updated: | September 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan Cancer Center:
|
Newly Diagnosed Multiple Myeloma |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Bortezomib Lenalidomide Doxorubicin BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 21, 2013