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

University of Michigan Rogel Cancer Center

Status and phase: Terminated; Phase 2

Conditions: Plasma Cell Leukemia; Multiple Myeloma

Treatments: Drug: Fludarabine/Busulfan x 4 days; Procedure: stem cell transplant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00615589

umcc 2007.074

HUM00014029

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Flu-Bu4

Experimental group

Description:

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Treatment:

Drug: Fludarabine/Busulfan x 4 days

Procedure: stem cell transplant