Trials Sponsors Conditions Drugs Pricing

Conditions

Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition

Keywords

monoclonal gammopathy of undetermined significanceisolated plasmacytoma of boneextramedullary plasmacytomarefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myeloma

Interventions

beta alethineDrug

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Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

LifeTime Pharmaceuticals
Industrylead

Study Sites (3)

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

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma CellPrecancerous ConditionsMonoclonal Gammopathy of Undetermined Significance

Interventions

alethine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

Suzin Mayerson, PhD
LifeTime Pharmaceuticals
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 1 2
Purpose: TREATMENT
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 6, 2000

First Posted

October 8, 2003

Study Start

August 2000

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

December 18, 2013

Record last verified: 2002-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00006466
Data provider: ClinicalTrials.gov
Source updated: 2013-12-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:03 UTC

Beta Alethine in Treating Patients With Myeloma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations