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| Sponsored by: |
Genta Incorporated |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017602 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of dexamethasone by making cancer cells more sensitive to the drug. It is not yet known if dexamethasone is more effective with or without oblimersen in treating multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with or without 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 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | Randomized Phase III Study of Dexamethasone With or Without Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Relapsed or Refractory Multiple Myeloma |
| Study Start Date: | December 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to response to prior therapy (relapsed vs refractory), prior autologous stem cell transplantation (yes vs no), and number of prior therapy regimens (1-2 vs 3-6). Patients are randomized to 1 of 2 treatment arms.
Arm I
Arm II
Courses repeat every 3 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: NOTE: This trial is being conducted at many institutions throughout the country. Please contact Genta for a site near you.
Progressive multiple myeloma defined by one of the following:
Progressive disease defined by at least 1 of the following:
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
More Information
| Study ID Numbers: | CDR0000068722, GENTA-GMY302, UF-G-29-2001 |
| Study First Received: | June 6, 2001 |
| Last Updated: | April 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00017602 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
Anti-Inflammatory Agents Dexamethasone Immunoproliferative Disorders Antineoplastic Agents, Hormonal Blood Protein Disorders Hematologic Diseases Hormone Antagonists Blood Coagulation Disorders Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases Antiemetics |
Paraproteinemias Hemostatic Disorders Hormones Glucocorticoids Multiple Myeloma Hemorrhagic Disorders Peripheral Nervous System Agents Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
|
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Dexamethasone acetate Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Vascular Diseases Gastrointestinal Agents Glucocorticoids Pharmacologic Actions Multiple Myeloma Neoplasms Autonomic Agents Peripheral Nervous System Agents Lymphoproliferative Disorders Central Nervous System Agents Neoplasms, Plasma Cell |