Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03)
Status: | Active, not recruiting |
---|---|
Conditions: | Hematology, Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 2/23/2019 |
Start Date: | January 14, 2014 |
End Date: | December 31, 2020 |
BMT-03: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Patients With Relapsed or Refractory Multiple Myeloma
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive
standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant
conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3
phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is
reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose
will be 9Gy.
standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant
conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3
phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is
reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose
will be 9Gy.
Inclusion Criteria:
1. Patients meeting criteria for symptomatic myeloma
2. Patients who have progressive myeloma following initial induction (patients may have
received any number of treatment regimens including prior autologous transplant)
3. Patient age 18-75 years at time of enrollment
4. Karnofsky performance status of ≥70
5. Cardiac function: LVEF >40%
6. Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of
normal
7. Renal: Creatinine clearance of >30mL/min, estimated or calculated
8. Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
Exclusion Criteria:
1. Patients with diagnosis of plasma cell leukemia
2. Patients with truly non secretory myeloma (patients with light chain disease are
eligible)
3. Pregnant or breast-feeding
4. Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if
there is evidence of response to medication. Eligibility of HIV infected patients will
be determined on a case-by-case basis.
5. Patients who have undergone prior allogeneic stem cell transplant
6. Prior solid organ transplant
7. Patients receiving prior radiation to more than 20% of bone marrow containing areas
We found this trial at
1
site
1801 West Taylor, Suite 1E
Chicago, Illinois 60612
Chicago, Illinois 60612
312.355.1625
Principal Investigator: Pritesh Patel, MD
Phone: 312-996-5762
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