Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma
NCT ID: NCT00054353
Last Updated: 2017-10-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2002-10-31
2012-10-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To evaluate the efficacy of this approach by determining the 1-year progression-free survival (PFS) and overall survival (OS).
II. To evaluate day 100 non-relapse mortality.
III. To determine the incidences of grades II-IV acute graft-versus-host disease (GVHD) and chronic extensive GVHD.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or thrice daily (TID) on days 0-40 with taper to day 96 (unrelated donors).
After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months, and then annually thereafter for 5 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Related Donor
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).
fludarabine phosphate
Given IV
melphalan
Given IV
total-body irradiation
Undergo TBI
mycophenolate mofetil
Given PO
cyclosporine
Given PO
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Undergo reduced-intensity allogeneic PBSCT
peripheral blood stem cell transplantation
Undergo reduced-intensity allogeneic PBSCT
laboratory biomarker analysis
Correlative studies
Unrelated Donor
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).
fludarabine phosphate
Given IV
melphalan
Given IV
total-body irradiation
Undergo TBI
mycophenolate mofetil
Given PO
cyclosporine
Given PO
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Undergo reduced-intensity allogeneic PBSCT
peripheral blood stem cell transplantation
Undergo reduced-intensity allogeneic PBSCT
laboratory biomarker analysis
Correlative studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fludarabine phosphate
Given IV
melphalan
Given IV
total-body irradiation
Undergo TBI
mycophenolate mofetil
Given PO
cyclosporine
Given PO
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Undergo reduced-intensity allogeneic PBSCT
peripheral blood stem cell transplantation
Undergo reduced-intensity allogeneic PBSCT
laboratory biomarker analysis
Correlative studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient received at least one prior autologous or syngeneic hematopoietic SCT (HSCT) and now has progressive disease (PD) (greater than 25% increase in serum or urine paraprotein levels compared to best response status after autograft or appearance of new lytic bone lesions or plasmocytomas)
* Patient is not able to collect autologous PBSC due to poor marrow reserve (insufficient HSC-mobilization: \< 2.5 x 10\^6 cluster of differentiation \[CD\]34+ cells/kg); or contraindications to undergoing HSC-mobilization; patient now has PD and has received at least 4 cycles of standard chemotherapy (e.g. vincristine sulfate, doxorubicin hydrochloride, and dexamethasone \[VAD\]) in the past
* Patients must have the capacity to give informed consent
* DONOR: Human leukocyte antigen (HLA) genotypically identical sibling or phenotypically matched relative
* DONOR: HLA phenotypically matched unrelated donor (according to Standard Practice HLA matching criteria)
* Matched for serologically recognized HLA-A or B or C antigens and at least five of six HLA-A or B or C alleles
* Matched for HLA DRB1 and DQB1 alleles (defined by high-resolution typing) at the allele level
* DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for PBSC collection
* DONOR: Donor must have adequate veins for leukapheresis or agree to placement of a temporary central venous catheter
Exclusion Criteria
* Left ventricular ejection fraction \< 40% or symptomatic heart failure; ejection fraction is required if age \> 50 years or there is a history of anthracycline exposure or history of cardiac disease
* Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bridging fibrosis, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3 mg/dL,or symptomatic biliary disease
* Diffusion capacity of carbon monoxide (DLCO) \< 50% (corrected) or receiving continuous supplemental oxygen
* Creatinine clearance \< 40 mL/min
* Patients with poorly controlled hypertension
* Seropositive for the human immunodeficiency virus (HIV)
* Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a \> 20% risk of disease recurrence
* Pregnancy or breastfeeding
* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
* Not fully recovered from previous high-dose therapy:
* Persistent mucositis and gastrointestinal symptoms requiring hyperalimentation and/or intravenous hydration
* On steroids for autologous/syngeneic GVHD
* On IV antibiotics for documented infections
* Cytomegalovirus (CMV)-antigenemia positive
* On ganciclovir or foscarnet for previous CMV reactivation/infection; off of this therapy for less than two weeks despite documented CMV-antigenemia- negativity (identification \[ID\] should be consulted if there is persistent CMV antigenemia post autograft)
* Ongoing radiotherapy
* Patients who meet any of these criteria may be discussed with the principal investigator for recommendations as to the timing of the allograft
* Patients with active bacterial or fungal infections unresponsive to medical therapy
* DONOR: Identical twin
* DONOR: Donors unwilling to donate PBSC
* DONOR: Pregnancy
* DONOR: Infection with 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
* DONOR: Age \< 12 years
* DONOR: A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marco Mielcarek
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marco Mielcarek
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
University of Torino
Torino, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2011-00386
Identifier Type: REGISTRY
Identifier Source: secondary_id
1743.00
Identifier Type: OTHER
Identifier Source: secondary_id
1743.00
Identifier Type: -
Identifier Source: org_study_id