NCT00006466

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2000

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

October 8, 2003

Completed
Last Updated

December 18, 2013

Status Verified

September 1, 2002

First QC Date

November 6, 2000

Last Update Submit

December 17, 2013

Conditions

Multiple Myeloma and Plasma Cell NeoplasmPrecancerous 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Victory Over Cancer

Rockville, Maryland, 20852, United States

Location

St. Vincents Comprehensive Cancer Center

New York, New York, 10011, United States

Location

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 DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesHypergammaglobulinemia

Study Officials

  • Suzin Mayerson, PhD

    LifeTime Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 6, 2000

First Posted

October 8, 2003

Study Start

August 1, 2000

Last Updated

December 18, 2013

Record last verified: 2002-09

Locations

US(3)