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Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers

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ClinicalTrials.gov Identifier: NCT00003163
Recruitment Status : Unknown
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2003
Last Update Posted : January 6, 2014
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE April 18, 2003
Last Update Posted Date January 6, 2014
Study Start Date  ICMJE September 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers
Official Title  ICMJE Myeloblative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and B-Cell Malignancies
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
Intervention  ICMJE
  • Biological: filgrastim
  • Biological: sargramostim
  • Drug: cyclophosphamide
  • Drug: melphalan
  • Procedure: autologous bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February¬†20,¬†2007)
10
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003163
Other Study ID Numbers  ICMJE CDR0000065959
MCW-96110
MCW-HRRC-29196
NCI-V97-1368
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: David H. Vesole, MD, PhD Medical College of Wisconsin
PRS Account National Cancer Institute (NCI)
Verification Date October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP