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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523049-83-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
| Sanofi | INDUSTRY |
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This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 (Phase I) | Experimental | First dose level of etentamig to be explored in combination with Isa-VRd |
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| Dose Level 2 (Phase I) | Experimental | Second dose level of etentamig to be explored in combination with Isa-VRd |
|
| RP2D in Phase II | Experimental | RP2D of etentamig to be explored in combination with Isa-VRd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etentamig | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (Phase I) | Number of dose-limiting toxicities (DLTs) in participants and rates of adverse events (AEs) of grade ≥2 and of severe AEs in participants | through induction treatment, on average 4 months |
| MRD negativity (Phase II) | MRD-negativity rate after 12 cycles (with a sensitivity of <10-5) | through consolidation phase completion, an average of 1 year |
| PFS | Progression-free survival | up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall response rate | up to 10 years |
| CR rate | Complete Response Rate | up to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katja Weisel | Contact | +4940-7410-0 | k.weisel@uke.de | |
| Lisa Leypoldt | Contact | +4940-7410-0 | l.leypoldt@uke.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000599209 | isatuximab |
| D000069286 | Bortezomib |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Isatuximab | Drug | Administered per the protocol |
|
| Bortezomib + Lenalidomide + Dexamethasone | Drug | Administered per the protocol |
|
| VGPR Rate | Very good partial response rate | up to 10 years |
| DoR | Duration of Response | up to 10 years |
| TTR | Time to response | up to 10 years |
| PFS2 | Progression free survival 2 | up to 10 years |
| OS | Overall survival | up to 10 years |
| MRD negativity | Minimal Residual Disease (MRD) Negativity Rate (10-5 to 10-6) | up to 10 years |
| Sustained MRD | Sustained MRD negativity rate (for a duration of 6-months, and multiples therof) | up to 10 years |
| MRD-negative CR | Rates of MRD-negative Complete Responses | up to 10 years |
| Sustained MRD-negative CR | Rate of Sustained MRD-negative Complete Response | up to 10 years |
| 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 |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |