CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
fludarabine phosphate +7 moredrug
Likely dose
Fludarabine phosphate and melphalan IV with total-body irradiation, followed by reduced-intensity allogeneic PBSCT with post-transplant mycophenolate mofetil (PO) and cyclosporine (PO)AI-extracted
Key inclusion· 5
  • ✓Meet Salmon and Durie criteria for multiple myeloma diagnosis
  • ✓Prior autologous or syngeneic HSCT with progressive disease (>25% increase in paraprotein or new lytic lesions/plasmacytomas)
  • ✓Unable to collect autologous PBSC (marrow reserve <2.5 x 10^6 CD34+ cells/kg or HSC-mobilization contraindications) with progressive disease after ≥4 cycles standard chemotherapy
  • ✓HLA-matched sibling donor (genotypically identical) or phenotypically matched relative
Key exclusion· 13
  • ✕Karnofsky score <60%
  • ✕LVEF <40% or symptomatic heart failure; EF required if age >50, anthracycline exposure, or cardiac disease history
  • ✕Severe liver disease: fulminant liver failure, cirrhosis with portal hypertension, hepatic encephalopathy, variceal bleeding, total bilirubin >3 mg/dL with viral hepatitis, or related hepatic dysfunction
  • ✕DLCO <50% (corrected) or requiring continuous supplemental oxygen

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00054353
NCT00054353Phase 2Completed
CompareCT.gov

Reduced-Intensity Allogeneic HSC Transplantation From HLA-Matched Related and Unrelated Donors for Patients With Multiple Myeloma - A Multi-Center Trial

Fred Hutchinson Cancer Center·interventional·Posted Feb 6, 2003·Updated Oct 16, 2017

In Brief

A Phase 2 clinical trial evaluating fludarabine phosphate, melphalan, and 6 other interventions for Refractory Multiple Myeloma. Completed, enrolled 16 participants across 2 sites in 2 countries.

Detailed Summary

This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from happening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Multiple Myeloma
CountriesItaly, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2003
Enrollment StartOct 1, 2002
Primary CompletionOct 1, 2009
Study CompletionOct 14, 2012
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 23.4 years ago

Interventions

fludarabine phosphatedrug

Given IV

melphalandrug

Given IV

total-body irradiationradiation

Undergo TBI

mycophenolate mofetildrug

Given PO

cyclosporinedrug

Given PO

nonmyeloablative allogeneic hematopoietic stem cell transplantationprocedure

Undergo reduced-intensity allogeneic PBSCT

peripheral blood stem cell transplantationprocedure

Undergo reduced-intensity allogeneic PBSCT

laboratory biomarker analysisother

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