ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-Cell Cancers

This study is ongoing, but not recruiting participants.

Sponsored by: Medical College of Wisconsin
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003163
  Purpose

RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have multiple myeloma or other B-cell cancers.


Condition Intervention Phase
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Drug: cyclophosphamide
Drug: filgrastim
Drug: melphalan
Drug: sargramostim
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Lymphoma    Multiple Myeloma   

Drug Information available for:   Cyclophosphamide    Filgrastim    Melphalan    Sargramostim    Granulocyte-macrophage colony-stimulating factor    Melphalan hydrochloride    Sarcolysin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Myeloblative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and B-Cell Malignancies

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   10
Study Start Date:   September 1997

Detailed Description:

OBJECTIVES:

  • Determine the safety and efficacy of myeloablative therapy with autologous hematopoietic stem cell transplantation in patients with multiple myeloma and other B-cell malignancies.
  • Determine the efficacy and pretransplantation prognostic factors associated with myeloablative therapy in these patients.
  • Determine engraftment kinetics of granulocytes and platelets, as well as blood product transfusion requirements following hematopoietic stem cell transplantation.

OUTLINE: Patients must have hematopoietic stem cell procurement completed prior to myeloablative therapy. Patients receive high dose chemotherapy with autologous hematopoietic stem cell transplantation and supportive care. Melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion. Peripheral blood stem cells and/or bone marrow is reinfused on day 0. Filgrastim (G-CSF) or sargramostim (GM-CSF) is administered beginning on day 1 posttransplantation and continuing until blood counts recover.

Patients who are not candidates for tandem transplant may receive melphalan plus total body irradiation (TBI). Melphalan is administered IV on day -4. Total body irradiation is administered three times a day on days -3 and -2 and twice on day -1. At least 4 hours must elapse between each treatment. Hematopoietic stem cells are reinfused on day -1 upon completion of TBI or on day 0.

If patient is ineligible for melphalan plus TBI, the alternative single high dose regimen of melphalan plus cyclophosphamide is administered. Melphalan, for these patients, is given in two equal doses on day -4 followed by two consecutive days of cyclophosphamide on days -3 and -2. Hematopoietic stem cells are reinfused on day 0.

A second transplant may be considered, preferably between 3 and 6 months after the first transplant. The preferred regimen for the second transplant is melphalan alone or melphalan plus TBI as described above. The alternative regimens for the second dose therapy are melphalan alone or melphalan plus cyclophosphamide. For patients receiving melphalan alone, melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion. Hematopoietic stem cells are reinfused on day 0 for both alternative regimens.

Patients are followed for response from treatment for a minimum of 4 weeks and then periodically for survival.

PROJECTED ACCRUAL: A minimum of 10 patients will be accrued for this study.

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

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed multiple myeloma or other B-cell malignancy including non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia, or amyloidosis

    • Non-Hodgkin's lymphoma with T-cell immunophenotypes included

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 2,000/mm^3 (unless due to disease)
  • Platelet count at least 100,000/mm^3 (unless due to disease)

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • LVEF at least 40%

Pulmonary:

  • DLCO or FVC and FEV1 at least 50% of predicted unless due to restriction from volume loss secondary to disease

Other:

  • HIV negative
  • No overt infection or unexplained fever requiring broad spectrum antibiotics
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 2 weeks since prior biologic therapy

Chemotherapy:

  • At least 2 weeks since other prior chemotherapy and recovered

Endocrine therapy:

  • At least 2 weeks since prior endocrine therapy
  • Concurrent steroids allowed

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003163

Locations
United States, Wisconsin
Medical College of Wisconsin    
      Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators
Medical College of Wisconsin

Investigators
Study Chair:     David H. Vesole, MD, PhD     Medical College of Wisconsin    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065959, MCW-96110, MCW-HRRC-29196, NCI-V97-1368
First Received:   November 1, 1999
Last Updated:   November 16, 2008
ClinicalTrials.gov Identifier:   NCT00003163
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma  
Waldenstrom macroglobulinemia  
stage I multiple myeloma  
stage II multiple myeloma  
stage III multiple myeloma  
stage III grade 1 follicular lymphoma  
stage III grade 2 follicular lymphoma  
stage III grade 3 follicular lymphoma  
stage III adult diffuse small cleaved cell lymphoma  
stage III adult diffuse mixed cell lymphoma  
stage III adult diffuse large cell lymphoma  
stage III adult immunoblastic large cell lymphoma  
stage III adult lymphoblastic lymphoma  
stage III adult Burkitt lymphoma  
stage IV grade 1 follicular lymphoma  
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma

Study placed in the following topic categories:
Melphalan
Blood Protein Disorders
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Hemorrhagic Disorders
Multiple myeloma
Lymphoma, Large-Cell, Immunoblastic
Waldenstrom macroglobulinemia
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Blood Coagulation Disorders
Vascular Diseases
Lymphoblastic lymphoma
Mantle cell lymphoma
Recurrence
Multiple Myeloma
Lymphatic Diseases
Amyloidosis

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers