Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- The Percentage of Patients Alive 1 Year Post Transplant
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Flu-Bu4
Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Intervention: Fludarabine/Busulfan x 4 days (Drug)
Flu-Bu4
Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Intervention: stem cell transplant (Procedure)
Outcomes
Primary Outcomes
The Percentage of Patients Alive 1 Year Post Transplant
Time Frame: 1 Year
The primary objective is overall survival, one year from the time of transplant.
Secondary Outcomes
- The Percentage of Patients Free From Progression at 1 Year(1 Year)
- Percentage of Patients With Treatment Related Mortality (TRM)(100 days, one-year)
- Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)(100 days, 2 years)
- Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression(3 years)