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Beta Alethine in Treating Patients With Myeloma

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
beta alethine
Sponsored by
LifeTime Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Clinic
  • Victory Over Cancer
  • St. Vincents Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 6, 2000
Last Updated
December 17, 2013
Sponsor
LifeTime Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00006466
Brief Title
Beta Alethine in Treating Patients With Myeloma
Official Title
Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2002
Overall Recruitment Status
Unknown status
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
LifeTime Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
beta alethine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzin Mayerson, PhD
Organizational Affiliation
LifeTime Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Victory Over Cancer
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
St. Vincents Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States

12. IPD Sharing Statement

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Beta Alethine in Treating Patients With Myeloma

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