Bryostatin 1 in Treating Patients With Relapsed Multiple Myeloma

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute Identifier:
First received: November 1, 1999
Last updated: April 3, 2013
Last verified: April 2013

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with relapsed multiple myeloma.

Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: bryostatin 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Study Start Date: January 1997
Study Completion Date: November 2000
Primary Completion Date: January 1999 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the efficacy of bryostatin 1 administered as a 72-hour continuous infusion in patients with relapsed multiple myeloma. II. Determine the qualitative and quantitative toxic effects of bryostatin 1 in these patients. III. Determine the duration of response and survival following bryostatin 1 in these patients.

OUTLINE: All patients receive bryostatin 1 by 72-hour continuous infusion every 2 weeks until disease progression or 2 courses beyond complete remission. Response is assessed after every 4 courses. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 15-25 evaluable patients will be entered into this study over 1.25 years.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Multiple myeloma of any stage that has failed 1 or 2 prior regimens (chemotherapy, biologic therapy, or both, or bone marrow transplantation) Evidence of disease progression required Ineligible for known treatment of higher potential efficacy One of the following protein criteria required: Quantifiable M-components of IgG, IgA, IgD, or IgE Urinary kappa or lambda light chain (Bence-Jones protein) excretion Re-treatment on this protocol allowed if disease relapsed after a complete remission

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 50,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Transaminases less than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of impaired cardiac status, e.g.: Severe coronary artery disease Cardiomyopathy Congestive heart failure Arrhythmia Other: No known AIDS or HIV infection No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Carcinoma in situ of the cervix No pregnant or nursing women Effective contraception required of fertile patients during and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy (8 weeks since mitomycin or nitrosoureas) and recovered Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since radiotherapy and recovered Surgery: Not specified

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Please refer to this study by its identifier: NCT00002907

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Ayad M. Al-Katib, MD, FACP Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00002907     History of Changes
Other Study ID Numbers: CDR0000065272, P30CA022453, WSU-C-1257, WSU-D-1257, NCI-T95-0062D
Study First Received: November 1, 1999
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Bryostatin 1
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015