Beta Alethine in Treating Patients With Myeloma

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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition
• Intervention / Treatment: Drug: beta alethine

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Victory Over Cancer
  • New York
    • New York, New York, United States, 10011
      • St. Vincents Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT

Collaborators and Investigators

• Sponsor: LifeTime Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2000

Study Registration Dates

• First Submitted: November 6, 2000
• First Submitted That Met QC Criteria: October 7, 2003
• First Posted (ESTIMATE): October 8, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: September 1, 2002

More Information

Terms related to this study

• Keywords: stage II multiple myeloma; stage III multiple myeloma; stage I multiple myeloma; refractory multiple myeloma; monoclonal gammopathy of undetermined significance; isolated plasmacytoma of bone; extramedullary plasmacytoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Precancerous Conditions
• Other Study ID Numbers: CDR0000068280; LIFETIME-LTP-99-01; LIFETIME-IRB-0300203