Beta Alethine in Treating Patients With Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006466
• Other study ID #: CDR0000068280
• Secondary ID: LIFETIME-LTP-99-
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: November 6, 2000
• Last updated: December 17, 2013
• Start date: August 2000

Study information

• Verified date: September 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma
• Precancerous Condition
• Precancerous Conditions

Intervention

Drug:
• beta alethine

Locations

Country	Name	City	State
United States	Emory Clinic	Atlanta	Georgia
United States	St. Vincents Comprehensive Cancer Center	New York	New York
United States	Victory Over Cancer	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
LifeTime Pharmaceuticals

Country where clinical trial is conducted

United States,