TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)

Completed · Phase 1

Conditions studied: Multiple Myeloma, Relapsed, Multiple Myeloma, Refractory to Standard Treatment

In brief

In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). This is a conventional 3+3 phase I trial with increasing doses of TMI from minimum 3Gy to Maximum 9Gy.

Key facts

Study ID

NCT02043847

Run by

University of Illinois at Chicago

People needed

12

Starts

2014-01-14

Expected to finish

2016-09-14

Last updated by the study team

2024-11-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients meeting criteria for symptomatic myeloma
• Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
• Patient age 18-75 years at time of enrollment
• Karnofsky performance status of ≥70
• Cardiac function: LVEF >40%
• Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
• Renal: Creatinine clearance of >30mL/min, estimated or calculated
• Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)

You may not qualify if…

• Patients with diagnosis of plasma cell leukemia
• Patients with truly non secretory myeloma (patients with light chain disease are eligible)
• Pregnant or breast-feeding
• 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.
• Patients who have undergone prior allogeneic stem cell transplant
• Prior solid organ transplant
• Patients receiving prior radiation to more than 20% of bone marrow containing areas

Where it is running

• University of Illinois Cancer Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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