Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI MSGCC-210421 NCI-5824, NCT00049374, 5824

Objectives

1. 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.
2. Determine the time to progression and duration of response in patients treated with this regimen.
3. Determine the toxicity of this regimen in these patients.
4. Correlate disease response (clinical outcome) with changes in Bcl-2 levels in patients treated with this regimen.
5. Determine the disease-free and overall survival of patients treated with this regimen.

Entry 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

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

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/mm³*
• Platelet count at least 50,000/mm³*

   [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

Expected Enrollment

A total of 10-46 patients will be accrued for this study within 10 months.

Outcomes

Complete and partial remission

Relationship between molecular and clinical outcomes

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.

Badros AZ, Goloubeva O, Rapoport AP, et al.: Phase II study of G3139, a Bcl-2 antisense oligonucleotide, in combination with dexamethasone and thalidomide in relapsed multiple myeloma patients. J Clin Oncol 23 (18): 4089-99, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

Ashraf Badros, MD, Protocol chair		Ph: 410-328-2565; 800-888-8823

Registry Information
Official Title		A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma
Trial Start Date		2002-09-01
Registered in ClinicalTrials.gov		NCT00049374
Date Submitted to PDQ		2002-09-11
Information Last Verified		2005-12-05
NCI Grant/Contract Number		U01-CA69854

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