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Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oblimersen sodium
dexamethasone
thalidomide
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Greenebaum Cancer Center at University of Maryland Medical Center
  • St. Vincent's Comprehensive Cancer Center - Manhattan

Outcomes

Primary Outcome Measures

Complete and partial remission

Secondary Outcome Measures

Relationship between molecular and clinical outcomes

Full Information

First Posted
November 12, 2002
Last Updated
October 15, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00049374
Brief Title
Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
refractory multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
oblimersen sodium
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
thalidomide
Primary Outcome Measure Information:
Title
Complete and partial remission
Secondary Outcome Measure Information:
Title
Relationship between molecular and clinical outcomes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf Z. Badros, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1592
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center - Manhattan
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15867202
Citation
Badros AZ, Goloubeva O, Rapoport AP, Ratterree B, Gahres N, Meisenberg B, Takebe N, Heyman M, Zwiebel J, Streicher H, Gocke CD, Tomic D, Flaws JA, Zhang B, Fenton RG. Phase II study of G3139, a Bcl-2 antisense oligonucleotide, in combination with dexamethasone and thalidomide in relapsed multiple myeloma patients. J Clin Oncol. 2005 Jun 20;23(18):4089-99. doi: 10.1200/JCO.2005.14.381. Epub 2005 May 2.
Results Reference
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Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

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