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Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse

NCT01794572 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-12-12

Study results available
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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.

Conditions

  • Multiple Myeloma in Relapse

Interventions

RADIATION

Total Bone Marrow Irradiation (TBMI) 8 Gy

Total Bone Marrow Irradiation (TBMI): 8 Gy

RADIATION

Total Bone Marrow Irradiation (TBMI) 10 Gy

Total Bone Marrow Irradiation (TBMI): 10 Gy

RADIATION

Total Bone Marrow Irradiation (TBMI): 12 Gy

Total Bone Marrow Irradiation (TBMI): 12 Gy

RADIATION

Total Bone Marrow Irradiation (TBMI): 14 Gy

Total Bone Marrow Irradiation (TBMI): 14 Gy

RADIATION

Total Bone Marrow Irradiation (TBMI): 16 Gy

Total Bone Marrow Irradiation (TBMI): 16 Gy

Sponsors & Collaborators

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • Stéphane A SUPIOT, MD, PhD · Institut de Cancerologie de l'Ouest

  • Philippe MOREAU, MD, PhD · University Hospital, CHU de NANTES

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-09
Primary Completion
2020-10-06
Completion
2020-10-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01794572 on ClinicalTrials.gov