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Sponsors and Collaborators: |
University of Maryland Greenebaum Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049374 |
RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the drugs.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and dexamethasone with oblimersen in treating patients who have relapsed or refractory multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: oblimersen sodium Drug: dexamethasone Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma |
Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: Patients receive induction therapy comprising oblimersen IV continuously on days 1-7, 22-28, and 43-49, oral dexamethasone on days 4-7, 25-28, and 46-49, and oral thalidomide daily beginning on day 4. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients with stable disease after induction therapy receive maintenance therapy comprising oblimersen IV continuously on days 1-7, oral dexamethasone on days 4-7, and oral thalidomide daily. Courses repeat every 35 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 10-46 patients will be accrued for this study within 10 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically and clinically confirmed multiple myeloma
Relapsed and/or refractory after chemotherapy or transplantation
Measurable disease defined by quantitative immune globulin levels in serum and/or urine and bone marrow plasmacytosis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201-1592 | |
United States, New York | |
St. Vincent's Comprehensive Cancer Center - Manhattan | |
New York, New York, United States, 10011 |
Study Chair: | Ashraf Z. Badros, MD | University of Maryland Greenebaum Cancer Center |
Study ID Numbers: | CDR0000258058, MSGCC-210421, NCI-5824 |
Study First Received: | November 12, 2002 |
Last Updated: | April 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00049374 History of Changes |
Health Authority: | United States: Federal Government |
refractory multiple myeloma |
Dexamethasone Anti-Inflammatory Agents Thalidomide Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders |
Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Angiogenesis Inhibitors Glucocorticoids Immunosuppressive Agents Multiple Myeloma Peripheral Nervous System Agents Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Immunologic Factors Thalidomide Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders |
Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Growth Substances Vascular Diseases Gastrointestinal Agents Angiogenesis Inhibitors Immunosuppressive Agents |