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NCT01794572 · OUTCOME

Safety Profile Recommended Dose for Phase-2 (RDP2)

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
1 year

What was measured

Safety profile: acute, short and middle term toxicities Recommended Dose for Phase-2 (RDP2) and Extended Cohort for 14 patients at this dose

Analysis population: The study was terminated prematurely, due to a lack of enrolments. The recommended dose for phase-2 has not been reached. No extended cohort has been performed

Groups in this outcome

Total Bone Marrow Irradiation (TBMI): 8 Gy

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.

Total Bone Marrow Irradiation (TBMI): 10 Gy

Cohort 2: 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.

Total Bone Marrow Irradiation (TBMI): 12 Gy

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.

Total Bone Marrow Irradiation (TBMI): 14 Gy

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.

Total Bone Marrow Irradiation (TBMI): 16 Gy

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Total Bone Marrow Irradiation (TBMI): 8 Gy3
Total Bone Marrow Irradiation (TBMI): 10 Gy3
Total Bone Marrow Irradiation (TBMI): 12 Gy6
Total Bone Marrow Irradiation (TBMI): 14 Gy1
Total Bone Marrow Irradiation (TBMI): 16 Gy0

Reported measurements

Source class 1

Recommended dose reached

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Bone Marrow Irradiation (TBMI): 8 Gy0Not reportedNot reportedNot reportedNot reported
Total Bone Marrow Irradiation (TBMI): 10 Gy0Not reportedNot reportedNot reportedNot reported
Total Bone Marrow Irradiation (TBMI): 12 Gy0Not reportedNot reportedNot reportedNot reported
Total Bone Marrow Irradiation (TBMI): 14 Gy0Not reportedNot reportedNot reportedNot reported
Total Bone Marrow Irradiation (TBMI): 16 Gy0Not reportedNot reportedNot reportedNot reported

Patients treated at lower dose levels

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Bone Marrow Irradiation (TBMI): 8 Gy3Not reportedNot reportedNot reportedNot reported
Total Bone Marrow Irradiation (TBMI): 10 Gy3Not reportedNot reportedNot reportedNot reported
Total Bone Marrow Irradiation (TBMI): 12 Gy6Not reportedNot reportedNot reportedNot reported
Total Bone Marrow Irradiation (TBMI): 14 Gy1Not reportedNot reportedNot reportedNot reported

Extended Cohort performed

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Bone Marrow Irradiation (TBMI): 8 Gy0Not reportedNot reportedNot reportedNot reported
Total Bone Marrow Irradiation (TBMI): 10 Gy0Not reportedNot reportedNot reportedNot reported
Total Bone Marrow Irradiation (TBMI): 12 Gy0Not reportedNot reportedNot reportedNot reported
Total Bone Marrow Irradiation (TBMI): 14 Gy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      title
      Recommended dose reached
    2. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        1
      title
      Patients treated at lower dose levels
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Extended Cohort performed
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      0
    units
    Participants
description
Safety profile: acute, short and middle term toxicities Recommended Dose for Phase-2 (RDP2) and Extended Cohort for 14 patients at this dose
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
    OG000
    title
    Total Bone Marrow Irradiation (TBMI): 8 Gy
  2. description
    Cohort 2: 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
    OG001
    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
    OG002
    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
    OG003
    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
    OG004
    title
    Total Bone Marrow Irradiation (TBMI): 16 Gy
param Type
COUNT_OF_PARTICIPANTS
population Description
The study was terminated prematurely, due to a lack of enrolments. The recommended dose for phase-2 has not been reached. No extended cohort has been performed
reporting Status
POSTED
time Frame
1 year
title
Safety Profile Recommended Dose for Phase-2 (RDP2)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice