Melphalan and Stem Cell Transplant Before Total-Body Irradiation and Donor Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma
NCT ID: NCT00003954
Last Updated: 2020-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
1999-03-31
Brief Summary
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Detailed Description
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I. To evaluate engraftment of human leukocyte antigen (HLA) identical peripheral blood stem cell (PBSC) allografts given after conditioning with total-body irradiation (TBI) (200 cGy) and post-grafting immunosuppression with cyclosporine (CSP)/mycophenolate mofetil (MMF) in myeloma patients initially cytoreduced with high-dose melphalan.
II. To evaluate non-relapse mortality at day 100 post allografting. III. To evaluate the efficacy of this allografting strategy in terms of long-term progression free survival (PFS).
OUTLINE:
CONDITIONING REGIMEN: Patients receive high-dose melphalan intravenously (IV) over 15-20 minutes on day -2.
TRANSPLANTATION: Patients undergo autologous bone marrow or PBSC transplantation (PBSCT) on day 0.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Beginning 40-120 days after autologous transplant, patients undergo TBI on day 0.
TRANSPLANTATION: Patients undergo donor PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV twice daily (BID) on days -1 and 0 and orally (PO) BID on days 1-80 with taper based on evaluation of disease response and graft-versus-host disease (GVHD). Patients also receive mycophenolate mofetil PO BID on days 0-27.
POST-TRANSPLANTATION DONOR LYMPHOCYTE INFUSION (DLI): Beginning 4 weeks after immunosuppression, patients achieving persistent or progressive disease may undergo DLI over 30 minutes every 4 weeks for up to 3 treatments.
After completion of study treatment, patients are followed up for 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (Melphalan and PBSCT before TBI and Donor PBSCT)
CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 15-20 minutes on day -2.
TRANSPLANTATION: Patients undergo autologous bone marrow or PBSCT on day 0.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Beginning 40-120 days after autologous transplant, patients undergo TBI on day 0.
TRANSPLANTATION: Patients undergo donor PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV BID on days -1 and 0 and PO BID on days 1-80 with taper based on evaluation of disease response and GVHD. Patients also receive mycophenolate mofetil PO BID on days 0-27.
POST TRANSPLANT DLI: Beginning 4 weeks after immunosuppression, patients achieving persistent or progressive disease may undergo DLI over 30 minutes every 4 weeks for up to 3 treatments.
melphalan
Given IV
autologous hematopoietic stem cell transplantation
Undergo autologous bone marrow or PBSCT
autologous bone marrow transplantation
Undergo autologous bone marrow or PBSCT
peripheral blood stem cell transplantation
Undergo autologous bone marrow or PBSCT
total-body irradiation
Undergo TBI
peripheral blood stem cell transplantation
Undergo donor PBSCT
cyclosporine
Given IV and PO
mycophenolate mofetil
Given PO
therapeutic allogeneic lymphocytes
Undergo DLI
Interventions
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melphalan
Given IV
autologous hematopoietic stem cell transplantation
Undergo autologous bone marrow or PBSCT
autologous bone marrow transplantation
Undergo autologous bone marrow or PBSCT
peripheral blood stem cell transplantation
Undergo autologous bone marrow or PBSCT
total-body irradiation
Undergo TBI
peripheral blood stem cell transplantation
Undergo donor PBSCT
cyclosporine
Given IV and PO
mycophenolate mofetil
Given PO
therapeutic allogeneic lymphocytes
Undergo DLI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Maloney
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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City of Hope
Duarte, California, United States
University of Colorado
Denver, Colorado, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
University of Torino
Torino, , Italy
Countries
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References
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Cooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187.
Other Identifiers
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NCI-2012-00670
Identifier Type: REGISTRY
Identifier Source: secondary_id
1383.00
Identifier Type: -
Identifier Source: org_study_id
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