Conditions: Multiple Myeloma, Relapsed Multiple Myeloma, Refractory to Standard Treatment
Keywords: Multiple Myeloma Relapsed Refractory Progressive Disease Symptomatic
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 12
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 3Gy with standard high dose melphalan prior to autologous stem cell rescue arm 2: 6Gy with standard high dose melphalan prior to autologous stem cell rescue arm 3: 9Gy with standard high dose melphalan prior to autologous stem cell rescue

Interventions: intervention 1: Total Marrow Irradiation intervention 2: Melphalan intervention 3: Filgrastim (G-CSF) intervention 4: Autologous transplant intervention 5: Total Marrow Irradiation intervention 6: Melphalan intervention 7: Filgrastim (G-CSF) intervention 8: Autologous transplant intervention 9: Total Marrow Irradiation intervention 10: Melphalan intervention 11: Filgrastim (G-CSF) intervention 12: Autologous transplant
Intervention descriptions: intervention 1: Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day intervention 2: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant intervention 3: Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days. intervention 4: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue intervention 5: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day intervention 6: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant intervention 7: Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days intervention 8: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue intervention 9: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day intervention 10: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant intervention 11: Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days intervention 12: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue

Protocol document: