Beta Alethine in Treating Patients With Myeloma

LifeTime Pharmaceuticals

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition

Treatments: Drug: beta alethine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00006466

LIFETIME-LTP-99-01

CDR0000068280

LIFETIME-IRB-0300203

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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