Multiple Myeloma in RelapseTOMMYNCT01794572
Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse
A study testing Total Bone Marrow Irradiation (TBMI) 8 Gy, Total Bone Marrow Irradiation (TBMI) 10 Gy and Total Bone Marrow Irradiation (TBMI): 12 Gy in people with Multiple Myeloma in Relapse, run by Institut Cancerologie de l'Ouest at 8 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma in Relapse
- What is being tested?
- Total Bone Marrow Irradiation (TBMI) 8 Gy, Total Bone Marrow Irradiation (TBMI) 10 Gy and Total Bone Marrow Irradiation (TBMI): 12 Gy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 8 sitesFrance
- Study dates
- 9 Apr 2013to 6 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple Myeloma in first relapse.
- In Complete or very good partial remission
- Available Collected Autologous Peripheral Stem cells: 2.5x106 CD34+/Kg
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CLCC Bergonie, service de radiotherapie
Bordeaux, 33076
CHU Haut-Leveque, service d'Hématologie
Bordeaux, 33604
CLCC Oscar Lambret, service de radiothérapie
Lille, 59020
CHU Claude Huriez, service d'hématologie
Lille, 59037
CHU Hotel-Dieu, service d'hématologie
Nantes, 44093
CLCC ICO, service de radiothérapie
Saint-Herblain, 44805
CLCC Paul Strauss, service de radiothérapie
Strasbourg, 67091
CHU Hautepierre, service d'hématologie
Strasbourg, 67098
About this study
Official title: Phase 1-2 Study of the Combination of Escalated Total Bone Marrow Irradiation (TBMI) by Helicoidal Tomotherapy and a Fixed High-dose Melphalan (140 mg/m²) Followed by Peripheral Stem Cell Rescue (PSC) in First Relapsed Multiple Myeloma.
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.
Read the 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.
- Conditions
- Multiple Myeloma in Relapse
- Being tested
- Total Bone Marrow Irradiation (TBMI) 8 Gy, Total Bone Marrow Irradiation (TBMI) 10 Gy, Total Bone Marrow Irradiation (TBMI): 12 Gy, Total Bone Marrow Irradiation (TBMI): 14 Gy, Total Bone Marrow Irradiation (TBMI): 16 Gy
- Keywords
- Multiple Myeloma, Relapse, Complete Remission, Very Good Partial Remission
- Medical subject headings
- Multiple Myeloma, Recurrence, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Bone Marrow Irradiation (TBMI) 8 GyRadiation
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): 12 GyRadiation
Total Bone Marrow Irradiation (TBMI): 12 Gy
Total Bone Marrow Irradiation (TBMI): 14 GyRadiation
Total Bone Marrow Irradiation (TBMI): 14 Gy
Total Bone Marrow Irradiation (TBMI): 16 GyRadiation
Total Bone Marrow Irradiation (TBMI): 16 Gy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Radiation: Total Bone Marrow Irradiation (TBMI): 16 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Safety Profile Recommended Dose for Phase-2 (RDP2)
Safety profile: acute, short and middle term toxicities Recommended Dose for Phase-2 (RDP2) and Extended Cohort for 14 patients at this dose
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study start9 Apr 2013
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Why it stopped: Low patient recruitement rate and modification of the therapeutic standard
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Total Bone Marrow Irradiation (TBMI) dose escalation
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane A SUPIOT, MD, PhD, Principal investigator, Institut de Cancerologie de l'OuestPhilippe MOREAU, MD, PhD, Principal investigator, University Hospital, CHU de NANTES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794572
- Sponsor's protocol ID
- ICO-2012-04
- Other IDs
- 2012-001473-91
- Acronym
- TOMMY
- Status last verified
- Nov 2025
- First submitted
- 15 Feb 2013
- Last updated
- 12 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18786784Somlo 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.
PubMed 21047977
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2 Study of the Combination of Escalated Total Bone Marrow Irradiation (TBMI) by Helicoidal Tomotherapy and a Fixed High-dose Melphalan (140 mg/m²) Followed by Peripheral Stem Cell Rescue (PSC) in First Relapsed Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT01794572
- Acronym / sponsor ID
- TOMMY / ICO-2012-04
- Conditions
- Multiple Myeloma in Relapse
- Keywords
- Multiple Myeloma, Relapse, Complete Remission, Very Good Partial Remission
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low patient recruitement rate and modification of the therapeutic standard
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 9 Apr 2013 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Posted 12 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Total Bone Marrow Irradiation (TBMI) dose escalation
| Arm | Type | Receives |
|---|---|---|
| Total Bone Marrow Irradiation (TBMI): 8 Gy | Experimental | Radiation: Total Bone Marrow Irradiation (TBMI) 8 GyCohort 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): 10 Gy | Experimental | Radiation: Total Bone Marrow Irradiation (TBMI) 10 GyCohort 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): 12 Gy | Experimental | Radiation: Total Bone Marrow Irradiation (TBMI): 12 GyCohort 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. |
| Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy | Experimental | Radiation: Total Bone Marrow Irradiation (TBMI): 14 GyCohort 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): 16 Gy | Experimental | Radiation: Total Bone Marrow Irradiation (TBMI): 16 GyCohort 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Multiple Myeloma in first relapse.
- In Complete or very good partial remission
- Available Collected Autologous Peripheral Stem cells: 2.5x106 CD34+/Kg
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Bone Marrow Irradiation (TBMI) 8 GyTotal Bone Marrow Irradiation (TBMI): 8 Gy | Radiation | Total Bone Marrow Irradiation (TBMI): 8 Gy |
| Total Bone Marrow Irradiation (TBMI) 10 GyTotal Bone Marrow Irradiation (TBMI): 10 Gy | Radiation | Total Bone Marrow Irradiation (TBMI): 10 Gy |
| Total Bone Marrow Irradiation (TBMI): 12 GyTotal Bone Marrow Irradiation (TBMI): 12 Gy | Radiation | Total Bone Marrow Irradiation (TBMI): 12 Gy |
| Total Bone Marrow Irradiation (TBMI): 14 GyTotal Bone Marrow Irradiation (TBMI): 14 Gy | Radiation | Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy |
| Total Bone Marrow Irradiation (TBMI): 16 GyTotal Bone Marrow Irradiation (TBMI): 16 Gy | Radiation | Total Bone Marrow Irradiation (TBMI): 16 Gy |
Primary outcome
Maximal Tolerated Dose, Type of DLTs
Time frame: 1 year
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 secondary outcome
Safety Profile Recommended Dose for Phase-2 (RDP2)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18786784Wong 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.
- Background: PubMed 21047977Somlo 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.
- Publication in International journal of radiation oncology . biology . physicsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane A SUPIOT, MD, PhD principal investigator
Institut de Cancerologie de l'Ouest
Philippe MOREAU, MD, PhD principal investigator
University Hospital, CHU de NANTES
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Bone Marrow Irradiation (TBMI) 8 Gy, Total Bone Marrow Irradiation (TBMI) 10 Gy and Total Bone Marrow Irradiation (TBMI): 12 Gy in people with Multiple Myeloma in Relapse, run by Institut Cancerologie de l'Ouest at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Tolerated Dose, Type of DLTs (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01794572, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.