Refractory Multiple Myeloma Clinical Trial
Official title:
Allogeneic Stem Cell Transplantation For Multiple Myeloma: A Two Step Approach To Reduce Toxicity Involving High Dose Melphalan and Autologous Stem Cell Transplant Followed By PBSC Allografting After Low Dose TBI
NCT number | NCT00003954 |
Other study ID # | 1383.00 |
Secondary ID | NCI-2012-00670P0 |
Status | Completed |
Phase | Phase 1/Phase 2 |
First received | |
Last updated | |
Start date | March 1999 |
Verified date | May 2019 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study donor bone marrow transplantation is divided into a two step process to try to significantly reduce the side effects of the procedure yet still provide patients with multiple myeloma the benefits of this procedure
Status | Completed |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | December 2002 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 65 Years |
Eligibility |
Inclusion Criteria: - Meet Salmon and Durie criteria for initial diagnosis of multiple myeloma; transplant will be offered to patients with stage II or III multiple myeloma (MM) at diagnosis or have received chemotherapy and/or radiation therapy for progressive MM after initial diagnosis of stage I disease - The patient must have the capacity to give informed consent - Have received at least 4 cycles of conventional dose chemotherapy for MM - DONOR: HLA genotypically identical sibling - DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for both peripheral blood stem cell (PBSC) allograft and subsequent DLI - DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian) - DONOR: Age < 75, older donors may be considered after consultation by Psychological Consultation Center (PCC) Exclusion Criteria: - Karnofsky score less than 60, unless due solely to myeloma - Left ventricular ejection fraction less than 40% - Bilirubin greater than 2 X the upper limit of normal - Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) > 2 X the upper limit of normal - Diffusion lung capacity of carbon monoxide (DLCO) < 50% (corrected) or receiving continuous supplemental oxygen - Patients with poorly controlled hypertension - Pregnancy - Seropositive for the human immunodeficiency virus - Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment - Creatinine clearance < 40 cc/min at the time of initial autografting evaluation - Prior autograft (can be treated on alternative protocol) - DONOR: Identical twin - DONOR: Age less than 12 years - DONOR: Pregnancy - DONOR: Infection with human immunodeficiency virus (HIV) - DONOR: Inability to achieve adequate venous access - DONOR: Known allergy to G-CSF - DONOR: Current serious systemic illness - DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) criteria for stem cell donation as described in the standard practice guidelines of the institution |
Country | Name | City | State |
---|---|---|---|
Italy | University of Torino | Torino | |
United States | University of Colorado | Denver | Colorado |
United States | City of Hope | Duarte | California |
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFS | The current study will be regarded as potentially efficacious if the observed 3-year PFS rate among all patients treated exceeds 30%. The Kaplan-Meier (KM) estimate of PFS will be used. | From the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission, up to 3 years | |
Primary | Decrease in the short-term transplant-related mortality | Day 100 after allograft | ||
Primary | Establish stable allogeneic engraftment (mixed or full donor chimerism) | At day 56 after allografting | ||
Secondary | Overall survival | Estimated by the method of Kaplan and Meier. Confidence intervals will be estimated. | Up to 3 years | |
Secondary | Relapse rate | Summarized using cumulative incidence estimates. Confidence intervals will be estimated. | Up to 3 years | |
Secondary | Response rate | Confidence intervals will be estimated. | Up to 3 years | |
Secondary | Ability to convert mixed to full donor chimerism with DLI | Confidence intervals will be estimated. | Up to 3 years |
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