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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001473-91 | EudraCT Number |
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Low patient recruitement rate and modification of the therapeutic standard
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Bone Marrow Irradiation (TBMI) 8 Gy | Radiation | Total Bone Marrow Irradiation (TBMI): 8 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Expressed as the Rate (%) of Complete Response and Very Good Partial Response | osteo-medullary PET fixations evaluation by FDG PET-Scan Disease-free survival at 1 year and Overall Survival | 1 and 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane A SUPIOT, MD, PhD | Institut de Cancerologie de l'Ouest | Principal Investigator |
| Philippe MOREAU, MD, PhD | University Hospital, CHU de NANTES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CLCC Bergonie, service de radiotherapie | Bordeaux | 33076 | France | |||
| CHU Haut-Leveque, service d'Hématologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18786784 | Background | 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. | |
| 21047977 |
| Label | URL |
|---|---|
| Publication in International journal of radiation oncology . biology . physics | View source |
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Study start date: April 9, 2013 Study completion date: October 6, 2020
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2017 |
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Total Bone Marrow Irradiation (TBMI) dose escalation
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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): 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. |
|
| Total Bone Marrow Irradiation (TBMI) 10 Gy | Radiation | Total Bone Marrow Irradiation (TBMI): 10 Gy |
|
| Total Bone Marrow Irradiation (TBMI): 12 Gy | Radiation | Total Bone Marrow Irradiation (TBMI): 12 Gy |
|
| Total Bone Marrow Irradiation (TBMI): 14 Gy | Radiation | Total Bone Marrow Irradiation (TBMI): 14 Gy |
|
| Total Bone Marrow Irradiation (TBMI): 16 Gy | Radiation | Total Bone Marrow Irradiation (TBMI): 16 Gy |
|
| Bordeaux |
| 33604 |
| France |
| CLCC Oscar Lambret, service de radiothérapie | Lille | 59020 | France |
| CHU Claude Huriez, service d'hématologie | Lille | 59037 | France |
| CHU Hotel-Dieu, service d'hématologie | Nantes | 44093 | France |
| CLCC ICO, service de radiothérapie | Saint-Herblain | 44805 | France |
| CLCC Paul Strauss, service de radiothérapie | Strasbourg | 67091 | France |
| CHU Hautepierre, service d'hématologie | Strasbourg | 67098 | France |
| 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. |
| FG001 | Total Bone Marrow Irradiation (TBMI): 10 Gy | Cohort 1: 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
The study was terminated prematurely, due to a lack of enrolments
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The study was terminated prematurely, due to a lack of enrolments | Posted | Count of Participants | Participants | 1 year |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | The study was terminated prematurely, due to a lack of enrolments. The recommended dose for phase-2 has not been reached. No extended cohort has been performed | Posted | Count of Participants | Participants | 1 year |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Efficacy Expressed as the Rate (%) of Complete Response and Very Good Partial Response | osteo-medullary PET fixations evaluation by FDG PET-Scan Disease-free survival at 1 year and Overall Survival | The study was terminated prematurely, due to a lack of enrolments | Posted | Count of Participants | Participants | 1 and 2 years |
|
The adverse events were collected from enrollment until 90 days post Autologous Peripheral Stem Cell (PSC) Rescue.
The study was terminated prematurely, due to a lack of enrolments. All Serious adverse events, adverse events and all-cause mortality are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG001 | 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. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | 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. | 0 | 6 | 2 | 6 | 6 | 6 |
| EG003 | 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. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG004 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDRA | Systematic Assessment | Acute Grade 3 diarrhoea related to Melphalan |
|
| Dyspnoea | Cardiac disorders | MEDRA | Systematic Assessment | Dyspnoea grade 3 related to anemia |
|
| Septic shock | Infections and infestations | MEDRA | Systematic Assessment | Septic shock grade 3 with febrile neutropenia |
|
| Device related sepsis | Infections and infestations | MEDRA | Systematic Assessment | Implanted-port-catheter-related sepsis caused by Staphylococcus aureus grade 3 |
|
| Severe cognitive distress | Nervous system disorders | MEDRA | Systematic Assessment | Severe cognitive distress associated to hypernatremia and febrile aplasia grade 3 |
|
| Pyrexia | General disorders | MEDRA | Systematic Assessment | Febrile episode consistent with engraftment syndrome following stem cell transplantation, grade 3 |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MEDRA | Systematic Assessment | Interstitial lung disease with cytokine release syndrome grade 3 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombopenia | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | Grade 3 and 4 |
|
| Sepsis | Infections and infestations | MEDRA | Systematic Assessment | Sepsis due to Staphylococcus hominis, grade 3 |
|
| Neutropenia | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | Grade 3 to 4 |
|
| Mucositis | Gastrointestinal disorders | MEDRA | Systematic Assessment | Grade 3 to 4 |
|
| Febrile aplasia | General disorders | MEDRA | Systematic Assessment | Grade 3 to 4 |
|
| Anemia | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | Grade 3 |
|
| Cystitis | Renal and urinary disorders | MEDRA | Systematic Assessment | Grade 3 |
|
| Diarrhoea | Gastrointestinal disorders | MEDRA | Systematic Assessment | Grade 3 |
|
| Hypocalcemia | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | Grade 4 |
|
| Hypokalemia | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | Grade 3 |
|
| Lymphopenia | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | Grade 3 to 4 |
|
| Leucopenia | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | Grade 3 to 4 |
|
| Diarrhea | Gastrointestinal disorders | MEDRA | Systematic Assessment | Grade 2 |
|
| Fever | General disorders | MEDRA | Systematic Assessment | Grade 2 |
|
| Thoracic pain | Respiratory, thoracic and mediastinal disorders | MEDRA | Systematic Assessment | Grade 2 |
|
| Acute renal failure | Renal and urinary disorders | MEDRA | Systematic Assessment | Grade 2 |
|
| Neuropathic flare-up | Nervous system disorders | MEDRA | Systematic Assessment | Grade 2 |
|
| Gastroenteritis | Gastrointestinal disorders | MEDRA | Systematic Assessment | Grade 2 |
|
| Atrial Fibrillation | Cardiac disorders | MEDRA | Systematic Assessment | Grade 2 |
|
| Vomiting | Gastrointestinal disorders | MEDRA | Systematic Assessment | Grade 1 |
|
| Radiodermatitis | Skin and subcutaneous tissue disorders | MEDRA | Systematic Assessment | Grade 1 |
|
| Streptococcus infection | Infections and infestations | MEDRA | Systematic Assessment | Grade 2 |
|
| Nausea | Gastrointestinal disorders | MEDRA | Systematic Assessment | Grade 1 |
|
| Lower limb edema | Musculoskeletal and connective tissue disorders | MEDRA | Systematic Assessment | Grade 2 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Stéphane SUPIOT | Institut de Cancérologie de l'Ouest | (+33) 2406799 00 | stephane.supiot@ico.unicancer.fr |
| Dec 10, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018450 | Disease Progression |
Not provided
Not provided
|
|
|
|
| Patients without DLT |
|
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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
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. |
| OG003 | 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. |
| OG004 | 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. |
|
|