Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

Stopped early · Phase 2

Conditions studied: Multiple Myeloma, Plasma Cell Leukemia

In brief

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.

Key facts

Study ID

NCT00615589

Run by

University of Michigan Rogel Cancer Center

People needed

22

Starts

2008-02-01

Expected to finish

2013-01-01

Last updated by the study team

2016-04-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Michigan,Department of Internal Med. Hematology- Oncology — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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