Trial Outcomes & Findings for Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse (NCT NCT01794572)

Last Updated: 2025-12-12

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

1 year

Results posted on

2025-12-12

Participant Flow

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

Participant milestones

Participant milestones
Measure	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 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.	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.
Overall Study STARTED	3	3	6	1
Overall Study COMPLETED	3	3	6	1
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Bone Marrow Irradiation (TBMI): 8 Gy n=3 Participants 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 n=3 Participants 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 n=6 Participants 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 n=1 Participants 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.	Total n=13 Participants Total of all reporting groups
Sex: Female, Male Male	3 Participants n=3 Participants	1 Participants n=3 Participants	4 Participants n=6 Participants	0 Participants n=1 Participants	0 Participants	8 Participants n=13 Participants
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=1 Participants	0 Participants	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants	1 Participants n=1 Participants	0 Participants	13 Participants n=13 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=1 Participants	0 Participants	0 Participants n=13 Participants
Sex: Female, Male Female	0 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=6 Participants	1 Participants n=1 Participants	0 Participants	5 Participants n=13 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	3 Participants n=3 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants	1 Participants n=1 Participants	—	13 Participants n=13 Participants

PRIMARY outcome

Timeframe: 1 year

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

Outcome measures

Outcome measures
Measure	Total Bone Marrow Irradiation (TBMI): 8 Gy n=3 Participants 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 n=3 Participants 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 n=6 Participants 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 n=1 Participants 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.
Maximal Tolerated Dose, Type of DLTs DLT: Severe sepsis	0 Participants	0 Participants	1 Participants	0 Participants	—
Maximal Tolerated Dose, Type of DLTs Patients without DLT	3 Participants	3 Participants	5 Participants	1 Participants	—

SECONDARY outcome

Timeframe: 1 year

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

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

Outcome measures

Outcome measures
Measure	Total Bone Marrow Irradiation (TBMI): 8 Gy n=3 Participants 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 n=3 Participants 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 n=6 Participants 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 n=1 Participants 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.
Safety Profile Recommended Dose for Phase-2 (RDP2) Extended Cohort performed	0 Participants	0 Participants	0 Participants	0 Participants	—
Safety Profile Recommended Dose for Phase-2 (RDP2) Recommended dose reached	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety Profile Recommended Dose for Phase-2 (RDP2) Patients treated at lower dose levels	3 Participants	3 Participants	6 Participants	1 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 and 2 years

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

osteo-medullary PET fixations evaluation by FDG PET-Scan Disease-free survival at 1 year and Overall Survival

Outcome measures

Outcome measures
Measure	Total Bone Marrow Irradiation (TBMI): 8 Gy n=3 Participants 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 n=3 Participants 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 n=6 Participants 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 n=1 Participants 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.
Efficacy Expressed as the Rate (%) of Complete Response and Very Good Partial Response Patients with very good partial response	1 Participants	1 Participants	3 Participants	0 Participants	—
Efficacy Expressed as the Rate (%) of Complete Response and Very Good Partial Response Patients with partial response	2 Participants	0 Participants	2 Participants	0 Participants	—
Efficacy Expressed as the Rate (%) of Complete Response and Very Good Partial Response Patients with complete response	0 Participants	2 Participants	1 Participants	1 Participants	—

Adverse Events

Total Bone Marrow Irradiation (TBMI): 8 Gy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Total Bone Marrow Irradiation (TBMI): 10 Gy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Total Bone Marrow Irradiation (TBMI): 12 Gy

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Total Bone Marrow Irradiation (TBMI): 14 Gy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Total Bone Marrow Irradiation (TBMI): 16 Gy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Total Bone Marrow Irradiation (TBMI): 8 Gy n=3 participants at risk 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 n=3 participants at risk 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 n=6 participants at risk 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 n=1 participants at risk 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.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Cardiac disorders Dyspnoea	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Infections and infestations Septic shock	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Infections and infestations Device related sepsis	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Nervous system disorders Severe cognitive distress	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/6 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/6 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.

Other adverse events

Other adverse events
Measure	Total Bone Marrow Irradiation (TBMI): 8 Gy n=3 participants at risk 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 n=3 participants at risk 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 n=6 participants at risk 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 n=1 participants at risk 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.
Infections and infestations Sepsis	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/6 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	100.0% 1/1 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Renal and urinary disorders Cystitis	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/6 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Blood and lymphatic system disorders Thrombopenia	66.7% 2/3 • Number of events 2 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	100.0% 3/3 • Number of events 3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	100.0% 6/6 • Number of events 8 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	100.0% 1/1 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Blood and lymphatic system disorders Neutropenia	66.7% 2/3 • Number of events 2 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	100.0% 3/3 • Number of events 4 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	66.7% 4/6 • Number of events 5 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	100.0% 1/1 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Gastrointestinal disorders Mucositis	66.7% 2/3 • Number of events 2 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	33.3% 2/6 • Number of events 2 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
General disorders Febrile aplasia	66.7% 2/3 • Number of events 2 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Blood and lymphatic system disorders Hypocalcemia	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Blood and lymphatic system disorders Hypokalemia	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Blood and lymphatic system disorders Lymphopenia	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	66.7% 2/3 • Number of events 2 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	66.7% 4/6 • Number of events 4 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	100.0% 1/1 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Blood and lymphatic system disorders Leucopenia	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	66.7% 2/3 • Number of events 2 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	33.3% 2/6 • Number of events 2 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 2 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
General disorders Fever	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/6 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Respiratory, thoracic and mediastinal disorders Thoracic pain	33.3% 1/3 • Number of events 2 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/6 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Renal and urinary disorders Acute renal failure	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/6 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Nervous system disorders Neuropathic flare-up	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/6 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Gastrointestinal disorders Gastroenteritis	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/6 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Cardiac disorders Atrial Fibrillation	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Gastrointestinal disorders Vomiting	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	33.3% 1/3 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/6 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Skin and subcutaneous tissue disorders Radiodermatitis	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Infections and infestations Streptococcus infection	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Gastrointestinal disorders Nausea	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
Musculoskeletal and connective tissue disorders Lower limb edema	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/3 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	16.7% 1/6 • Number of events 1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	0.00% 0/1 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.	— 0/0 • The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue. The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.

Additional Information

Pr Stéphane SUPIOT

Institut de Cancérologie de l'Ouest

Phone: (+33) 2406799 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place