Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Condition: Multiple Myeloma; Plasma Cell Leukemia
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia, Plasma Cell
Intervention: Fludarabine/Busulfan x 4 days; stem cell transplant
Intervention description: 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.; Allogeneic, peripheral blood stem cell transplant
Intervention MeSH terms: Fludarabine; Busulfan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Stage II/III Multiple Myeloma(within 10 months from diagnosis); high risk; relapse; persistent

Summary:

      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.
    

Eligibility criteria:

        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