Working… Menu

Beta Alethine in Treating Patients With Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006466
Recruitment Status : Unknown
Verified September 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2003
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Drug: beta alethine Phase 1 Phase 2

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma
Study Start Date : August 2000

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • At least 4 months


  • 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


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


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


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


  • 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


Biologic therapy:

  • At least 4 weeks since prior immunotherapy or cytokines


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

Endocrine therapy:

  • No concurrent corticosteroids


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


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006466

Layout table for location information
United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
United States, Maryland
Victory Over Cancer
Rockville, Maryland, United States, 20852
United States, New York
St. Vincents Comprehensive Cancer Center
New York, New York, United States, 10011
Sponsors and Collaborators
LifeTime Pharmaceuticals
Layout table for investigator information
Study Chair: Suzin Mayerson, PhD LifeTime Pharmaceuticals

Layout table for additonal information Identifier: NCT00006466     History of Changes
Other Study ID Numbers: CDR0000068280
First Posted: October 8, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: September 2002
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Precancerous Conditions
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cystine Depleting Agents
Molecular Mechanisms of Pharmacological Action