TriangleNCT00615589 · REGISTRY CONDITION SEARCH
Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2016-04-04
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
The Percentage of Patients Alive 1 Year Post Transplant
The Percentage of Patients Free From Progression at 1 Year
Percentage of Patients With Treatment Related Mortality (TRM)
Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)
Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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
- healthy Volunteers
- false
- maximum Age
- 70 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
- intervention Names
- Drug: Fludarabine/Busulfan x 4 days
- Procedure: stem cell transplant
- label
- Flu-Bu4
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Flu-Bu4
- 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.
- name
- Fludarabine/Busulfan x 4 days
- type
- DRUG
- arm Group Labels
- Flu-Bu4
- description
- Allogeneic, peripheral blood stem cell transplant
- name
- stem cell transplant
- type
- PROCEDURE
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 22
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The primary objective is overall survival, one year from the time of transplant.
- measure
- The Percentage of Patients Alive 1 Year Post Transplant
- time Frame
- 1 Year
- secondary Outcomes
- description
- One of the secondary outcomes that will be measured is progression free survival at 1 Year. Progressive Disease (PD) is defined as a \>25% increase in serum monoclonal paraprotein, a \>25% increase in 24-hour urinary light chain excretion, a \>25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.
- measure
- The Percentage of Patients Free From Progression at 1 Year
- time Frame
- 1 Year
- measure
- Percentage of Patients With Treatment Related Mortality (TRM)
- time Frame
- 100 days, one-year
- description
- Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed. Acute GVHD Grading: Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, \>1500ml/day diarrhea Stage IV - Skin, bullae; Liver, \>15mg/dl bilirubin; Gut, pain +/- ileus
- measure
- Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)
- time Frame
- 100 days, 2 years
- description
- Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.
- measure
- Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression
- time Frame
- 3 years
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
- release id
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- source file
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Preserved source evidence · Not medical advice