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| Sponsor: | Oncotherapeutics |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00742404 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome together with bortezomib and dexamethasone works in treating patients with newly diagnosed multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Drug: dexamethasone Drug: pegylated liposomal doxorubicin hydrochloride Genetic: protein analysis Other: immunologic technique |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethasone (DVD) for Patients With Newly Diagnosed Multiple Myeloma (MM) |
| Estimated Enrollment: | 35 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive pegylated liposomal doxorubicin hydrochloride IV over 30-90 minutes, dexamethasone IV, and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Blood and urine samples are collected at baseline and periodically during study for M-protein analysis by electrophoresis and immunofixation.
After completion of study therapy, patients are followed periodically.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma based on the following criteria:
Major criteria
Minor criteria
Meets 1 of the following sets of diagnostic criteria:
Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike ≥ 200 mg/24 hours, or evidence of lytic bone disease
PATIENT CHARACTERISTICS:
No impaired cardiac function or clinically significant cardiac disease, including any one of the following:
ECG evidence of acute ischemia or active conduction system abnormalities
No known HIV positivity or hepatitis B or C positivity
PRIOR CONCURRENT THERAPY:
No prior or concurrent anti-myeloma therapy except steroids
More than 4 weeks since prior major surgery and recovered
Contacts and Locations| United States, Arizona | |
| Arizona Clinical Research Center, Incorporated | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Comprehensive Blood and Cancer Center | |
| Bakersfield, California, United States, 93309-0633 | |
| San Diego Pacific Oncology and Hematology Associates, Incorporated - Escondido | |
| Escondido, California, United States, 92025 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Oncology Care Medical Associates - San Gabriel | |
| Los Angeles, California, United States, 90057 | |
| Desert Cancer Care | |
| Rancho Mirage, California, United States, 92270 | |
| Sutter Cancer Center at Roseville Medical Center | |
| Roseville, California, United States, 95661 | |
| Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara | |
| Santa Barbara, California, United States, 93105 | |
| James R. Berenson MD, Incorporated | |
| West Hollywood, California, United States, 90069 | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, New York | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, South Carolina | |
| Charleston Hematology Oncology Associates, PA | |
| Charleston, South Carolina, United States, 29403 | |
| Principal Investigator: | James R. Berenson, MD | Oncotherapeutics |
More Information
| Responsible Party: | Regulatory Affairs Associate, Oncotherapeutics |
| ClinicalTrials.gov Identifier: | NCT00742404 History of Changes |
| Other Study ID Numbers: | CDR0000612434, ONCOTHER-X05272-DOXILMMY2010, DVD study |
| Study First Received: | August 26, 2008 |
| Last Updated: | June 25, 2010 |
| Health Authority: | United States: Federal Government |
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type 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 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 |