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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00049374
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 17, 2019
National Cancer Institute (NCI)
University of Maryland Greenebaum Cancer Center
Information provided by:
University of Maryland, Baltimore

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Biological: oblimersen sodium Drug: dexamethasone Drug: thalidomide Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (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
Study Start Date : September 2002
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Primary Outcome Measures :
  1. Complete and partial remission

Secondary Outcome Measures :
  1. Relationship between molecular and clinical outcomes

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months


  • 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)


  • Bilirubin less than 2 times normal
  • AST/ALT no greater than 3 times upper limit of normal


  • Creatinine no greater than 2 mg/dL


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • 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


Biologic therapy

  • See Disease Characteristics
  • See Chemotherapy
  • At least 6 weeks since prior thalidomide


  • 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


  • Not specified


  • Not specified


  • No prior oblimersen
  • No other concurrent anticancer therapies or investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00049374

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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
Sponsors and Collaborators
University of Maryland, Baltimore
National Cancer Institute (NCI)
University of Maryland Greenebaum Cancer Center
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Study Chair: Ashraf Z. Badros, MD University of Maryland Greenebaum Cancer Center
Publications of Results:
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Responsible Party: UM Greenebaum Cancer Center Identifier: NCT00049374    
Other Study ID Numbers: CDR0000258058
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Keywords provided by University of Maryland, Baltimore:
refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents