Filgrastim Compared With Sargramostim Plus Chemotherapy, Peripheral Stem Cell Transplantation, and Interferon Alfa in Treating Patients With Multiple Myeloma

NCT00005987 | Terminated Phase 2 DMC

• 3 other identifiers: 1996LS137UMN-MT-9216UMN-MT-1992-16
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as filgrastim and sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Interferon alfa may interfere with the growth of cancer cells. It is not yet known which treatment regimen is more effective for multiple myeloma. PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim with that of sargramostim plus chemotherapy, peripheral stem cell transplantation, and interferon alfa in treating patients who have multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Interventions

carmustine DRUG

cyclophosphamide DRUG

dexamethasone DRUG

etoposide DRUG

filgrastim DRUG

mitoxantrone hydrochloride DRUG

recombinant interferon alfa DRUG

sargramostim DRUG

bone marrow ablation with stem cell support PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy PROCEDURE

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma * Complete or partial remission after initial therapy OR * Complete or partial response to therapy after disease progression following initial therapy * No plasma cell leukemia (greater than 10% circulating plasma cells) * No advanced myeloma refractory and unresponsive to at least 2 salvage chemotherapy regimens PATIENT CHARACTERISTICS: Age: * 70 and under Performance status: * Age 65-70 years: * Karnofsky 80-100% * Under 65 years: * Not specified Life expectancy: * Not specified Hematopoietic: * Hemoglobin at least 8 g/dL (untransfused) * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 (untransfused) Hepatic: * Bilirubin less than 2.0 mg/dL * ALT less than 3 times upper limit of normal Renal: * Age 65-70 years: * Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL) * Under 65 years: * Creatinine less than 2 mg/dL Cardiovascular: * Age 65-70 years: * LVEF at least 45% * Under 65 years: * No active ischemia * LVEF greater than 45% by MUGA Pulmonary: * Age 65-70 years: * If history of smoking or respiratory symptoms, spirometry and DLCO must be greater than 50% of predicted * Under 65 years: * FEV\_1 and FVC greater than 60% predicted * DLCO greater than 50% of predicted Other: * No active or uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * Not specified

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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Carmustine; Cyclophosphamide; Dexamethasone; Etoposide; Filgrastim; Mitoxantrone; Interferon-alpha; sargramostim; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Carbohydrates; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Anthraquinones; Anthrones; Anthracenes; Quinones; Interferon Type I; Interferons; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Daniel J. Weisdorf, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Primary Completion: July 1, 2003
• Study Completion: July 1, 2003
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)