Status:
TERMINATED
Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Multiple Myeloma in Relapse
Eligibility:
All Genders
18-65 years
Phase:
NA
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). H...
Detailed Description
Experimental : Total Bone Marrow Irradiation (TBMI) is delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3. The escalated dose levels are d...
Eligibility Criteria
Inclusion
- Multiple Myeloma in first relapse.
- In Complete or very good partial remission
- Available Collected Autologous Peripheral Stem cells: 2.5x106 CD34+/Kg
Exclusion
- 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
Key Trial Info
Start Date :
April 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01794572
Start Date
April 9 2013
End Date
October 6 2020
Last Update
December 12 2025
Active Locations (8)
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1
CLCC Bergonie, service de radiotherapie
Bordeaux, France, 33076
2
CHU Haut-Leveque, service d'Hématologie
Bordeaux, France, 33604
3
CLCC Oscar Lambret, service de radiothérapie
Lille, France, 59020
4
CHU Claude Huriez, service d'hématologie
Lille, France, 59037