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NCT01794572 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
TERMINATED
Registry last update
2025-12-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximal Tolerated Dose, Type of DLTs

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outcome · POSTED

Safety Profile Recommended Dose for Phase-2 (RDP2)

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Multiple Myeloma in first relapse. * In Complete or very good partial remission * Available Collected Autologous Peripheral Stem cells: 2.5x106 CD34+/Kg Exclusion Criteria: * 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
healthy Volunteers
false
maximum Age
65 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Radiation: Total Bone Marrow Irradiation (TBMI) 8 Gy
    label
    Total Bone Marrow Irradiation (TBMI): 8 Gy
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Radiation: Total Bone Marrow Irradiation (TBMI) 10 Gy
    label
    Total Bone Marrow Irradiation (TBMI): 10 Gy
    type
    EXPERIMENTAL
  3. description
    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.
    intervention Names
    1. Radiation: Total Bone Marrow Irradiation (TBMI): 12 Gy
    label
    Total Bone Marrow Irradiation (TBMI): 12 Gy
    type
    EXPERIMENTAL
  4. description
    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.
    intervention Names
    1. Radiation: Total Bone Marrow Irradiation (TBMI): 14 Gy
    label
    Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy
    type
    EXPERIMENTAL
  5. description
    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.
    intervention Names
    1. Radiation: Total Bone Marrow Irradiation (TBMI): 16 Gy
    label
    Total Bone Marrow Irradiation (TBMI): 16 Gy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Total Bone Marrow Irradiation (TBMI): 8 Gy
    description
    Total Bone Marrow Irradiation (TBMI): 8 Gy
    name
    Total Bone Marrow Irradiation (TBMI) 8 Gy
    type
    RADIATION
  2. arm Group Labels
    1. Total Bone Marrow Irradiation (TBMI): 10 Gy
    description
    Total Bone Marrow Irradiation (TBMI): 10 Gy
    name
    Total Bone Marrow Irradiation (TBMI) 10 Gy
    type
    RADIATION
  3. arm Group Labels
    1. Total Bone Marrow Irradiation (TBMI): 12 Gy
    description
    Total Bone Marrow Irradiation (TBMI): 12 Gy
    name
    Total Bone Marrow Irradiation (TBMI): 12 Gy
    type
    RADIATION
  4. arm Group Labels
    1. Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy
    description
    Total Bone Marrow Irradiation (TBMI): 14 Gy
    name
    Total Bone Marrow Irradiation (TBMI): 14 Gy
    type
    RADIATION
  5. arm Group Labels
    1. Total Bone Marrow Irradiation (TBMI): 16 Gy
    description
    Total Bone Marrow Irradiation (TBMI): 16 Gy
    name
    Total Bone Marrow Irradiation (TBMI): 16 Gy
    type
    RADIATION
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
intervention Model Description
Total Bone Marrow Irradiation (TBMI) dose escalation
masking Info
masking
NONE
primary Purpose
OTHER
Enrollment
count
13
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    osteo-medullary PET fixations evaluation by FDG PET-Scan Disease-free survival at 1 year and Overall Survival
    measure
    Efficacy Expressed as the Rate (%) of Complete Response and Very Good Partial Response
    time Frame
    1 and 2 years
primary Outcomes
  1. description
    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.
    measure
    Maximal Tolerated Dose, Type of DLTs
    time Frame
    1 year
secondary Outcomes
  1. description
    Safety profile: acute, short and middle term toxicities Recommended Dose for Phase-2 (RDP2) and Extended Cohort for 14 patients at this dose
    measure
    Safety Profile Recommended Dose for Phase-2 (RDP2)
    time Frame
    1 year
Full study description
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.
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 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.
Source references
references
  1. citation
    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
    18786784
    type
    BACKGROUND
  2. citation
    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
    21047977
    type
    BACKGROUND
see Also Links
  1. label
    Publication in International journal of radiation oncology . biology . physics
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice