Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma |
- Complete and partial remission [ Designated as safety issue: No ]
- Relationship between molecular and clinical outcomes [ Designated as safety issue: No ]
| Study Start Date: | September 2002 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the clinical efficacy of oblimersen, thalidomide, and dexamethasone, in terms of complete and partial response rates, in patients with relapsed or refractory multiple myeloma.
- Determine the time to progression and duration of response in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate disease response (clinical outcome) with changes in Bcl-2 levels in patients treated with this regimen.
- Determine the disease-free and overall survival of patients treated with this regimen.
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.
Eligibility| 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
- Patients with prior allogeneic transplantation must not have evidence of active graft-vs-host disease requiring immune suppression
Measurable disease defined by quantitative immune globulin levels in serum and/or urine and bone marrow plasmacytosis
- Patients with nonsecretory disease are eligible provided at least 1 plasmacytoma lesion is accurately measurable by MRI or CT scan
- No known CNS involvement
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 3 months
Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count at least 1,000/mm^3*
- Platelet count at least 50,000/mm^3* NOTE: *Unless secondary to bone marrow plasmacytosis (more than 80% involvement)
Hepatic
- Bilirubin less than 2 times normal
- AST/ALT no greater than 3 times upper limit of normal
Renal
- Creatinine no greater than 2 mg/dL
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Seizures allowed if under adequate control
- No severe skin reactions from prior thalidomide
- No prior allergic reactions attributed to agents used in this study
- No sensory or motor neuropathy grade II or greater
- No other uncontrolled concurrent illness that would preclude study therapy
- No ongoing or active infection
- No psychiatric illness or social situations that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods of contraception for 1 month before, during, and for 1 month after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- See Chemotherapy
- At least 6 weeks since prior thalidomide
Chemotherapy
- See Disease Characteristics
- No more than 4 prior chemotherapy regimens, including autologous and/or allogeneic stem cell transplantation regimens
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
- Concurrent continuous steroids allowed for chronic treatment of disorders other than myeloma
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior oblimersen
- No other concurrent anticancer therapies or investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | UM Greenebaum Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00049374 History of Changes |
| Other Study ID Numbers: | CDR0000258058, MSGCC-210421, NCI-5824 |
| Study First Received: | November 12, 2002 |
| Last Updated: | September 23, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Maryland:
|
refractory multiple myeloma |
Additional relevant MeSH terms:
|
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 Thalidomide 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 Glucocorticoids |
ClinicalTrials.gov processed this record on June 18, 2013