Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse (TOMMY)
Multiple Myeloma in Relapse
About this trial
This is an interventional treatment trial for Multiple Myeloma in Relapse focused on measuring Multiple Myeloma, Relapse, Complete Remission, Very Good Partial Remission
Eligibility Criteria
Inclusion Criteria:
- Multiple Myeloma in first relapse.
- In Complete or very good partial remission
- Available Collected Autologous Peripheral Stem cells: 2.5x106 CD34+/Kg
Exclusion Criteria:
- Uncontrolled visceral disease: kidney, heart, lung, diabetes mellitus
- Previous Total body irradiation
- Any previous radiation dose to the spinal cord which could reach to 45gy equivalent, including the proposed TBMI
- Amyloidosis
- Brain localizations
Sites / Locations
- CLCC Bergonie, service de radiotherapie
- CHU Haut-Leveque, service d'Hématologie
- CLCC Oscar Lambret, service de radiothérapie
- CHU Claude Huriez, service d'hématologie
- CHU Hotel-Dieu, service d'hématologie
- CLCC ICO, service de radiothérapie
- CLCC Paul Strauss, service de radiothérapie
- CHU Hautepierre, service d'hématologie
Arms of the Study
Arm 1
Experimental
Total BM irradiation dose
Total Bone Marrow Irradiation (TBMI) is delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. The escalated dose levels are determined according to a "3x3" modified Fibonacci method and five dose levels will be explored. The doses per fraction are: 1gy, 1.25gy, 1.5gy, 1.75gy and 2gy, and consequently the cumulative TBMI doses are: 8gy, 10gy, 12gy, 14gy and 16gy. For Every patients: Drug : Melphalan is infused intravenously in 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue : are re-infused in the central line on day "0" after adequate premedication.