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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: National Cancer Institute (NCI); University of Maryland Greenebaum Cancer Center
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Oblimersen; Thalidomide

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