NCT01794572 · OUTCOME

Maximal Tolerated Dose, Type of DLTs

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

Maximal Tolerated Dose Type of Dose-limiting Toxicities 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.

Analysis population: The study was terminated prematurely, due to a lack of enrolments

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

Group	Source count
Total Bone Marrow Irradiation (TBMI): 8 Gy	3
Total Bone Marrow Irradiation (TBMI): 10 Gy	3
Total Bone Marrow Irradiation (TBMI): 12 Gy	6
Total Bone Marrow Irradiation (TBMI): 14 Gy	1
Total Bone Marrow Irradiation (TBMI): 16 Gy	0

Reported measurements

Source class 1

DLT: Severe sepsis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Total Bone Marrow Irradiation (TBMI): 8 Gy	0	Not reported	Not reported	Not reported	Not reported
Total Bone Marrow Irradiation (TBMI): 10 Gy	0	Not reported	Not reported	Not reported	Not reported
Total Bone Marrow Irradiation (TBMI): 12 Gy	1	Not reported	Not reported	Not reported	Not reported
Total Bone Marrow Irradiation (TBMI): 14 Gy	0	Not reported	Not reported	Not reported	Not reported

Patients without DLT

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Total Bone Marrow Irradiation (TBMI): 8 Gy	3	Not reported	Not reported	Not reported	Not reported
Total Bone Marrow Irradiation (TBMI): 10 Gy	3	Not reported	Not reported	Not reported	Not reported
Total Bone Marrow Irradiation (TBMI): 12 Gy	5	Not reported	Not reported	Not reported	Not reported
Total Bone Marrow Irradiation (TBMI): 14 Gy	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
DLT: Severe sepsis
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
5
group Id
OG003
value
1
title
Patients without DLT

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
6
group Id
OG003
value
1
group Id
OG004
value
0
units
Participants

description

groups

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
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
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
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
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

reporting Status

POSTED

time Frame

1 year

title

Maximal Tolerated Dose, Type of DLTs

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice