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
|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|
|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|
|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|
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.
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|
|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 Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|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|
|NCT Number ICMJE||NCT00003163|
|Other Study ID Numbers ICMJE||CDR0000065959
|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|
|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