This trial is active, not recruiting.

Conditions multiple myeloma, plasma cell leukemia
Treatments fludarabine/busulfan x 4 days, stem cell transplant
Phase phase 2
Sponsor University of Michigan Cancer Center
Collaborator Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date February 2008
End date June 2014
Trial size 40 participants
Trial identifier NCT00615589, HUM00014029, umcc 2007.074


Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem cell transplant - a procedure where the patient is treated with high dose chemotherapy and then their own (autologous) stem cells are transplanted back into their body. Patients with multiple myeloma and high risk genes, always relapse after an autologous transplant and often die within two years from the time of their transplant. A different type of transplant allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the donor cells may help kill the lymphoid cancer cells.

This study will investigate if a matched donor stem cell transplant using a newer, reduced toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple Myeloma.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
fludarabine/busulfan x 4 days
Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.
stem cell transplant
Allogeneic, peripheral blood stem cell transplant

Primary Outcomes

overall survival, one year from the time of transplant
time frame: one-year

Secondary Outcomes

Progression free survival
time frame: one-year
Treatment-related mortality
time frame: 100 days, one-year
Incidence of acute and chronic GVHD
time frame: 100 days, 2 years
Non relapse mortality
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Biologic high risk Multiple Myeloma: - Stage II/III Multiple Myeloma, any of: t(4; 14), t(14; 16),(14:20) by Fish; 17P- by conventional cytogenetics or Fish; ∆13 by conventional cytogenetics; Hypodiploidy by conventional cytogenetics. - Relapsed or persistent multiple myeloma after ASCT. - Persistent multiple myeloma, regardless of previous therapies. - Plasma cell leukemia, regardless of previous therapies. - Age up to 70 years old (less than 71 years old at the date of transplant admission). - Disease status: in CR, nCR, VGPR, PR or stable disease within 1 month of admission - Patients with non-secretory and oligosecretory disease are eligible if they meet certain criteria within 2 weeks prior to the transplant. - Specific renal, liver, cardiac, and pulmonary function requirements(all must be met within 30 days of transplant admission) Exclusion Criteria: - Persistent invasive infections, not controlled by antimicrobials. - HIV-1/HIV-2 or HTLV-1/HTLV-2 seropositivity. - Uncontrolled medical or psychiatric disorder. - No response or progressive disease at the time of transplantation. - Pregnancy

Additional Information

Official title Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Principal investigator Attaphol Pawarode, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.