Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse
Status:
Terminated
Trial end date:
2020-01-07
Target enrollment:
Participant gender:
Summary
In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow
(BM), dramatic recent progresses have been observed, thanks to new agents (proteasome
inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem
Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to
healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation. Modern
irradiation modalities are now available by the use of HI-ART Tomotherapy system to realize a
Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered to Organ
at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study, the
conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a dose
escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting
Toxicities (DLT). An extended cohort will further in a phase-2 setting.