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Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition

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Trial Information

Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Suzin Mayerson, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

LifeTime Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000068280

NCT ID:

NCT00006466

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous Condition
  • 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
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Precancerous Conditions

Name

Location

St. Vincents Comprehensive Cancer CenterNew York, New York  10011
Emory ClinicAtlanta, Georgia  30365
Victory Over CancerRockville, Maryland  20852