Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma - Full Text View

Sponsor:	University of Maryland
Collaborators:	National Cancer Institute (NCI) University of Maryland Greenebaum Cancer Center
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00049374

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Thalidomide Dexamethasone acetate Doxiproct plus Oblimersen sodium Dexamethasone Sodium Phosphate

U.S. FDA Resources

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

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

National Cancer Institute (NCI)

University of Maryland Greenebaum Cancer Center

Investigators

Study Chair:

Ashraf Z. Badros, MD

University of Maryland Greenebaum Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2005 May 2.

Responsible Party:	UM Greenebaum Cancer Center
Study ID Numbers:	CDR0000258058, MSGCC-210421, NCI-5824
Study First Received:	November 12, 2002
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00049374 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Maryland:

refractory multiple myeloma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Immunologic Factors
Thalidomide
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders

Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Growth Substances
Vascular Diseases
Gastrointestinal Agents
Angiogenesis Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on November 30, 2009