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

This study has been completed.
Sponsor:
Collaborators:
University of Maryland Greenebaum Cancer Center
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00049374
First received: November 12, 2002
Last updated: September 23, 2009
Last verified: September 2009
  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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Complete and partial remission [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049374

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
Sponsors and Collaborators
University of Maryland
University of Maryland Greenebaum Cancer Center
Investigators
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 September 11, 2014