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

NCT00049374 | Completed Phase 2

• 3 other identifiers: CDR0000258058MSGCC-210421NCI-5824
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Complete and partial remission

Secondary Outcomes (1)

• Relationship between molecular and clinical outcomes

Interventions

oblimersen sodium BIOLOGICAL

dexamethasone DRUG

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Cancer Institute (NCI): collaborator
• University of Maryland Greenebaum Cancer Center: collaborator

Study Sites (2)

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201-1592, United States

Location

St. Vincent's Comprehensive Cancer Center - Manhattan

New York, New York, 10011, United States

Location

Related Publications (1)

• 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.

  PMID: 15867202 RESULT

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

oblimersen; Dexamethasone; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ashraf Z. Badros, MD

  University of Maryland Greenebaum Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

US (2)