Beta Alethine in Treating Patients With Myeloma

NCT ID: NCT00006466

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31

Brief Summary

RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have myeloma.

Detailed Description

OBJECTIVES:

• Determine the antitumor effects of low-dose beta alethine in patients with myeloma or progressive monoclonal gammopathy of undetermined significance.
• Determine the effects of this regimen on anemia, performance status, pain, and delayed-type hypersensitivity (immune response) in these patients.
• Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive beta alethine subcutaneously every 2 weeks for 6 doses. At day 85, patients may receive an additional 12-week course of therapy in the absence of disease progression or unacceptable toxicity. Patients with an apparent complete response receive additional courses.

Patients are followed for 2 weeks.

PROJECTED ACCRUAL: A total of 13-37 patients will be accrued for this study.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition

Keywords

monoclonal gammopathy of undetermined significance; isolated plasmacytoma of bone; extramedullary plasmacytoma; refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

beta alethine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically proven myeloma

• Multiple myeloma
• Indolent myeloma with slowly progressive bone pathology
• Smoldering myeloma with no bone pathology but a progressive increase in M-protein
• Solitary myeloma OR
• Diagnosis of evolving monoclonal gammopathy of undetermined significance with increasing M-protein or decreasing hemoglobin level
• Measurable M-protein or Bence Jones protein
• Indolent disease not requiring therapy allowed
• No clinical signs or evidence of active brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 50-100%

Life expectancy:

• At least 4 months

Hematopoietic:

• See Disease Characteristics
• Neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin less than 2.0 mg/dL
• Transaminases no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/dL
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No acute changes on electrocardiogram
• No uncontrolled angina, heart failure, or arrhythmia

Other:

• Adequate nutritional status (total protein at least 60.0 g/L, albumin at least 35 g/L)
• HIV negative
• No AIDS
• No active bacterial infection (e.g., abscess) or with fistula
• No history of alcoholism, drug addiction, or psychotic disorders that would preclude study
• No other nonmalignant disease that would preclude study
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy or cytokines

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin)

Endocrine therapy:

• No concurrent corticosteroids

Radiotherapy:

• No prior radiotherapy to greater than 25% of bone marrow

Surgery:

• Recovered from any prior surgery
• No prior solid organ transplantation

Other:

• No other concurrent investigational agent
• No concurrent immunosuppressive agents
• No concurrent anti-inflammatory agents, including aspirin or over-the-counter or prescription nonsteroidal anti-inflammatory drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LifeTime Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Suzin Mayerson, PhD

Role: STUDY_CHAIR

LifeTime Pharmaceuticals

Locations

Emory Clinic

Atlanta, Georgia, United States

Victory Over Cancer

Rockville, Maryland, United States

St. Vincents Comprehensive Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

LIFETIME-LTP-99-01

Identifier Type: -

Identifier Source: secondary_id

LIFETIME-IRB-0300203

Identifier Type: -

Identifier Source: secondary_id

CDR0000068280

Identifier Type: -

Identifier Source: org_study_id