Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse
NCT ID: NCT01794572
Last Updated: 2025-12-12
Study Results
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View full resultsBasic Information
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TERMINATED
NA
13 participants
INTERVENTIONAL
2013-04-09
2020-10-06
Brief Summary
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Detailed Description
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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 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.
Drug : Melphalan is infused intravenously in 30 minutes on day -2 after IV anti-emetics.
Autologous Peripheral Stem Cell Rescue : are re-infused in the central line on day "0" after adequate premedication.
Despite the recent finding of new drugs (proteasome inhibitors and IMIDs), Multiple Myeloma still remain uncurable, especially after the first relapse, even in responding disease under conventional chemotherapy. In the healthy youngest patients (\<65 yo), when peripheral stem cells collection is available, a high-dose therapy is often proposed in consolidation of complete or very good partial remission: the conditioning regimen usually includes high dose alkylating agent (mostly Melphalan) and/or Total Body Irradiation. The new Tomotherapy HI-ART technology allows irradiating on a 1.6m length field all the bone marrow sites together with optimal respect of the Organ at Risk (lungs, oral cavity, heart, liver, kidneys…). The proposed phase-1 study will explore the safety and efficacy of escalated dose of Total Bone-Marrow Irradiation in combination with a fixed dose of Melphalan (140mg/m²), followed by autologous SCR. To determine the MTD is the main objective of the study, then the toxicity profile (DLTs) and the RP2D in an extended cohort at the MTD dose.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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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) 8 Gy
Total Bone Marrow Irradiation (TBMI): 8 Gy
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) 10 Gy
Total Bone Marrow Irradiation (TBMI): 10 Gy
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): 12 Gy
Total Bone Marrow Irradiation (TBMI): 12 Gy
Cohort 4: 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): 14 Gy
Total Bone Marrow Irradiation (TBMI): 14 Gy
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 Bone Marrow Irradiation (TBMI): 16 Gy
Total Bone Marrow Irradiation (TBMI): 16 Gy
Interventions
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Total Bone Marrow Irradiation (TBMI) 8 Gy
Total Bone Marrow Irradiation (TBMI): 8 Gy
Total Bone Marrow Irradiation (TBMI) 10 Gy
Total Bone Marrow Irradiation (TBMI): 10 Gy
Total Bone Marrow Irradiation (TBMI): 12 Gy
Total Bone Marrow Irradiation (TBMI): 12 Gy
Total Bone Marrow Irradiation (TBMI): 14 Gy
Total Bone Marrow Irradiation (TBMI): 14 Gy
Total Bone Marrow Irradiation (TBMI): 16 Gy
Total Bone Marrow Irradiation (TBMI): 16 Gy
Eligibility Criteria
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Inclusion Criteria
* In Complete or very good partial remission
* Available Collected Autologous Peripheral Stem cells: 2.5x106 CD34+/Kg
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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Principal Investigators
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Stéphane A SUPIOT, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancerologie de l'Ouest
Philippe MOREAU, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, CHU de NANTES
Locations
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CLCC Bergonie, service de radiotherapie
Bordeaux, , France
CHU Haut-Leveque, service d'Hématologie
Bordeaux, , France
CLCC Oscar Lambret, service de radiothérapie
Lille, , France
CHU Claude Huriez, service d'hématologie
Lille, , France
CHU Hotel-Dieu, service d'hématologie
Nantes, , France
CLCC ICO, service de radiothérapie
Saint-Herblain, , France
CLCC Paul Strauss, service de radiothérapie
Strasbourg, , France
CHU Hautepierre, service d'hématologie
Strasbourg, , France
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Publication in International journal of radiation oncology . biology . physics
Other Identifiers
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2012-001473-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ICO-2012-04
Identifier Type: -
Identifier Source: org_study_id
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