CClinicalTrials.gg
Status unknownNCT00006466Updated Dec 18, 2013

Beta Alethine in Treating Patients With Myeloma

A Phase 1/2 interventional study of beta alethine in Multiple Myeloma and Plasma Cell Neoplasm and Precancerous Condition, sponsored by LifeTime Pharmaceuticals. Status unknown at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-18.

Sponsored by LifeTime Pharmaceuticals · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2002), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

Browse Multiple Myeloma studies →

Lead sponsor

LifeTime Pharmaceuticals is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment

Interventions

  • Drugbeta alethine
06

Study locations

3 sites
  • Emory Clinic
    Atlanta, Georgia 30322, United States
  • Victory Over Cancer
    Rockville, Maryland 20852, United States
  • St. Vincents Comprehensive Cancer Center
    New York, New York 10011, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00006466
Lead sponsor
LifeTime Pharmaceuticals
First posted
Oct 8, 2003
Start date
Aug 2000
Last update
Dec 18, 2013

Study contacts

Suzin Mayerson, PhD
study chair · LifeTime Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2002. You cannot join it, but the record below documents what was studied.

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