Participant flow

Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse · Source last updated 2025-12-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Cohort 1: Total Bone Marrow Irradiation (TBMI): 8 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue : re-infused in the central line on day "0" after adequate premedication.

   id

   FG000

   title

   Total Bone Marrow Irradiation (TBMI): 8 Gy

2. description

   Cohort 1: Total Bone Marrow Irradiation (TBMI): 10 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue : re-infused in the central line on day "0" after adequate premedication.

   id

   FG001

   title

   Total Bone Marrow Irradiation (TBMI): 10 Gy

3. description

   Cohort 3: Total Bone Marrow Irradiation (TBMI): 12 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue : re-infused in the central line on day "0" after adequate premedication.

   id

   FG002

   title

   Total Bone Marrow Irradiation (TBMI): 12 Gy

4. description

   Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue : re-infused in the central line on day "0" after adequate premedication.

   id

   FG003

   title

   Total Bone Marrow Irradiation (TBMI): 14 Gy

5. description

   Cohort 5: Total Bone Marrow Irradiation (TBMI): 16 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. Melphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics. Autologous Peripheral Stem Cell Rescue : re-infused in the central line on day "0" after adequate premedication.

   id

   FG004

   title

   Total Bone Marrow Irradiation (TBMI): 16 Gy

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Study start date: April 9, 2013 Study completion date: October 6, 2020

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice