NCT01794572

Brief Summary

In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow (BM), dramatic recent progresses have been observed, thanks to new agents (proteasome inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation. Modern irradiation modalities are now available by the use of HI-ART Tomotherapy system to realize a Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered to Organ at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study, the conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a dose escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLT). An extended cohort will further in a phase-2 setting.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 9, 2013

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

December 12, 2025

Completed
Last Updated

December 12, 2025

Status Verified

November 1, 2025

Enrollment Period

7.5 years

First QC Date

February 15, 2013

Results QC Date

September 10, 2025

Last Update Submit

December 10, 2025

Conditions

Multiple Myeloma in Relapse

Keywords

Multiple MyelomaRelapseComplete RemissionVery Good Partial Remission

Outcome Measures

Primary Outcomes (1)

  • Maximal Tolerated Dose, Type of DLTs

    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.

    1 year

Secondary Outcomes (1)

  • Safety Profile Recommended Dose for Phase-2 (RDP2)

    1 year

Other Outcomes (1)

  • Efficacy Expressed as the Rate (%) of Complete Response and Very Good Partial Response

    1 and 2 years

Study Arms (5)

Total Bone Marrow Irradiation (TBMI): 8 Gy

EXPERIMENTAL

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.

Radiation: Total Bone Marrow Irradiation (TBMI) 8 Gy

Total Bone Marrow Irradiation (TBMI): 10 Gy

EXPERIMENTAL

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.

Radiation: Total Bone Marrow Irradiation (TBMI) 10 Gy

Total Bone Marrow Irradiation (TBMI): 12 Gy

EXPERIMENTAL

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.

Radiation: Total Bone Marrow Irradiation (TBMI): 12 Gy

Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy

EXPERIMENTAL

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.

Radiation: Total Bone Marrow Irradiation (TBMI): 14 Gy

Total Bone Marrow Irradiation (TBMI): 16 Gy

EXPERIMENTAL

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.

Radiation: Total Bone Marrow Irradiation (TBMI): 16 Gy

Interventions

Total Bone Marrow Irradiation (TBMI) 8 GyRADIATION

Total Bone Marrow Irradiation (TBMI): 8 Gy

Total Bone Marrow Irradiation (TBMI): 8 Gy
Total Bone Marrow Irradiation (TBMI) 10 GyRADIATION

Total Bone Marrow Irradiation (TBMI): 10 Gy

Total Bone Marrow Irradiation (TBMI): 10 Gy
Total Bone Marrow Irradiation (TBMI): 12 GyRADIATION

Total Bone Marrow Irradiation (TBMI): 12 Gy

Total Bone Marrow Irradiation (TBMI): 12 Gy
Total Bone Marrow Irradiation (TBMI): 14 GyRADIATION

Total Bone Marrow Irradiation (TBMI): 14 Gy

Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy
Total Bone Marrow Irradiation (TBMI): 16 GyRADIATION

Total Bone Marrow Irradiation (TBMI): 16 Gy

Total Bone Marrow Irradiation (TBMI): 16 Gy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Multiple Myeloma in first relapse.
  • In Complete or very good partial remission
  • Available Collected Autologous Peripheral Stem cells: 2.5x106 CD34+/Kg

You may not qualify if:

  • Uncontrolled visceral disease: kidney, heart, lung, diabetes mellitus
  • Previous Total body irradiation
  • Any previous radiation dose to the spinal cord which could reach to 45gy equivalent, including the proposed TBMI
  • Amyloidosis
  • Brain localizations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CLCC Bergonie, service de radiotherapie

Bordeaux, 33076, France

Location

CHU Haut-Leveque, service d'Hématologie

Bordeaux, 33604, France

Location

CLCC Oscar Lambret, service de radiothérapie

Lille, 59020, France

Location

CHU Claude Huriez, service d'hématologie

Lille, 59037, France

Location

CHU Hotel-Dieu, service d'hématologie

Nantes, 44093, France

Location

CLCC ICO, service de radiothérapie

Saint-Herblain, 44805, France

Location

CLCC Paul Strauss, service de radiothérapie

Strasbourg, 67091, France

Location

CHU Hautepierre, service d'hématologie

Strasbourg, 67098, France

Location

Related Publications (2)

  • Wong JY, Rosenthal J, Liu A, Schultheiss T, Forman S, Somlo G. Image-guided total-marrow irradiation using helical tomotherapy in patients with multiple myeloma and acute leukemia undergoing hematopoietic cell transplantation. Int J Radiat Oncol Biol Phys. 2009 Jan 1;73(1):273-9. doi: 10.1016/j.ijrobp.2008.04.071. Epub 2008 Sep 9.

    PMID: 18786784BACKGROUND

  • Somlo G, Spielberger R, Frankel P, Karanes C, Krishnan A, Parker P, Popplewell L, Sahebi F, Kogut N, Snyder D, Liu A, Schultheiss T, Forman S, Wong JY. Total marrow irradiation: a new ablative regimen as part of tandem autologous stem cell transplantation for patients with multiple myeloma. Clin Cancer Res. 2011 Jan 1;17(1):174-82. doi: 10.1158/1078-0432.CCR-10-1912. Epub 2010 Nov 3.

    PMID: 21047977BACKGROUND

Related Links

MeSH Terms

Conditions

Multiple MyelomaRecurrencePathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Progression

Results Point of Contact

Title
Pr Stéphane SUPIOT
Organization
Institut de Cancérologie de l'Ouest
stephane.supiot@ico.unicancer.fr
(+33) 2406799 00

Study Officials

  • Stéphane A SUPIOT, MD, PhD

    Institut de Cancerologie de l'Ouest

    PRINCIPAL INVESTIGATOR

  • Philippe MOREAU, MD, PhD

    University Hospital, CHU de NANTES

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Total Bone Marrow Irradiation (TBMI) dose escalation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 20, 2013

Study Start

April 9, 2013

Primary Completion

October 6, 2020

Study Completion

October 6, 2020

Last Updated

December 12, 2025

Results First Posted

December 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(8)