Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

NCT00014508 | Completed Phase 2

• 2 other identifiers: CDR0000068551ECOG-E4A98
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 12

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 be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are rejected by the body's tissues. Peripheral stem cell transplantation with the person's own stem cells followed by donor peripheral stem cell transplantation may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with autologous peripheral stem cell transplantation and donor peripheral stem cell transplantation in treating patients who have multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Interventions

sargramostim BIOLOGICAL

cyclophosphamide DRUG

cyclosporine DRUG

fludarabine phosphate DRUG

melphalan DRUG

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma meeting 1 of the following criteria: * Bone marrow plasmacytosis with at least 10% plasma cells * Sheets of plasma cells * Biopsy-proven plasmacytoma * Meets at least 1 of the following criteria: * Presence of myeloma (M)-protein in the serum * Presence of M-protein in the urine * Radiographic evidence of osteolytic lesions * Generalized osteoporosis allowed if at least 20% plasma cells in bone marrow * No non-secretory myeloma * Prior M-protein in serum or urine allowed provided patient is now in complete remission * Must be receiving conventional-dose chemotherapy as initial therapy or as salvage therapy * Must have HLA-A, -B, and -DR genotypically identical sibling donor PATIENT CHARACTERISTICS: Age: * 18 to 70 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * AST no greater than 3 times upper limit of normal * Bilirubin less than 2.0 mg/dL Renal: * Not specified Cardiovascular: * LVEF greater than 40% at rest if symptomatic cardiac disease is present Pulmonary: * DLCO greater than 50% of predicted (corrected for hemoglobin) if symptomatic pulmonary disease is present Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior autologous or allogeneic peripheral blood stem cell or bone marrow transplantation Chemotherapy: * See Disease Characteristics * More than 28 days since prior chemotherapy (including primary chemotherapy for hematopoietic stem cell collection) * No other concurrent cytotoxic chemotherapy between autologous and allogeneic transplantation Endocrine therapy: * Prior dexamethasone or other corticosteroids allowed * Concurrent corticosteroids between autologous and allogeneic transplantation allowed Radiotherapy: * Concurrent radiotherapy between autologous and allogeneic transplantation allowed Surgery: * Not specified

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

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207-8554, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Cancer Center at Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MBCCOP-Our Lady of Mercy Cancer Center

The Bronx, New York, 10466, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106-5065, United States

Location

MetroHealth's Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Vesole DH, Zhang L, Flomenberg N, Greipp PR, Lazarus HM, Huff CA; ECOG Myeloma and BMT Committees. A Phase II trial of autologous stem cell transplantation followed by mini-allogeneic stem cell transplantation for the treatment of multiple myeloma: an analysis of Eastern Cooperative Oncology Group ECOG E4A98 and E1A97. Biol Blood Marrow Transplant. 2009 Jan;15(1):83-91. doi: 10.1016/j.bbmt.2008.10.030.

  PMID: 19135946 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

sargramostim; Cyclophosphamide; Cyclosporine; fludarabine phosphate; Melphalan; Peripheral Blood Stem Cell Transplantation

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)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Neal Flomenberg, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: January 27, 2003
• Study Start: November 19, 2001
• Primary Completion: February 1, 2007
• Study Completion: May 27, 2011
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (12)