Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BMS-986395, Abecma, bb2121, ide-cel
idecabtagene vicleucel · 6 trials · 1 indication
PFS as assessed by Independent Review Committee (IRC)
Time from randomization to the first documentation of progressive disease based on the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma assessed by an independent response committee (IRC) or death due to any cause, whichever occurs first.
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Percentage of subjects who achieved CR or stringent CR according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Number of participants who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an independent response committee (IRC).
DLTs will be assessed during the DLT interval (ie, within 21 days immediately after bb2121 infusion). DLTs are defined as any bb2121 related Grade 3 to 5 toxicity.
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | - |
| Arm B | ACTIVE_COMPARATOR | - |
| Arm A - Administration of bb2121 | EXPERIMENTAL | bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy |
| Arm B- standard regimens as per Investigator's discretion | EXPERIMENTAL | The participants will receive one of following regimens dependent on the subject's most recent anti-myeloma treatment regimen: * Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (dex) (DPd) OR * DARA in combination with bortezomib (BTZ) and low-dose dex (DVd) OR * Ixazomib (IXA) in combination with lenalidomide (LEN) and low-dose dex (IRd) OR * Carfilzomib (CFZ) in combination with low-dose dexamethasone (Kd) OR * Elotuzumab (ELO) in combination with POM and low-dose dexamethasone (EPd) |
| Cohort 1: BB2121 in relapsed and refractory multiple myeloma participants | EXPERIMENTAL | bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy |
| Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participants | EXPERIMENTAL | - |
| Cohort 2a: BB2121 in multiple myeloma with Autologous stem cell transplantation participants | EXPERIMENTAL | - |
| Cohort 2b: BB2121 in multiple myeloma without Autologous stem cell transplantation participants | EXPERIMENTAL | - |
| Cohort 2c: BB2121 in multiple myeloma participants with inadequate response post ASCT | EXPERIMENTAL | - |
| Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myeloma | EXPERIMENTAL | - |
| Administration of bb2121 | EXPERIMENTAL | bb2121 autologous CAR T cells will be infused at a dose ranging from 15 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy. |
| Dose Escalation | EXPERIMENTAL | * bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 800 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy with a planned starting dose of 450 x 10\^6 CAR+ T cells. * Lenalidomide maintenance therapy is recommended for all patients and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later |
| bb2121 | EXPERIMENTAL | bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy |
| Name | Type | Description |
|---|---|---|
| idecabtagene vicleucel | BIOLOGICAL | Specified dose on specified days |
| Lenalidomide | DRUG | Specified dose on specified days |
| Fludarabine | DRUG | Specified dose on specified days |
| Cyclophosphamide | DRUG | Specified dose on specified days |
| bb2121 | BIOLOGICAL | bb2121 |
| Daratumumab | DRUG | Daratumumab |
| Pomalidomide | DRUG | Pomalidomide |
| Dexamethasone | DRUG | Dexamethasone |
| Bortezomib | DRUG | Bortezomib |
| Ixazomib | DRUG | Ixazomib |
| Carfilzomib | DRUG | Carfilzomib |
| Elotuzumab | DRUG | Elotuzumab |
| Lenalomide | DRUG | Specified dose on specified days |
| Talquetamab | DRUG | Specified dose on specified days |
Inclusion Criteria * Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of...
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Idecabtagene vicleucel is a CAR-T cell therapy being developed by Bristol-Myers Squibb Company for multiple myeloma, a cancer of plasma cells in the bone marrow. It is an investigational treatment currently in Phase 3 clinical development, studied in adults with newly diagnosed multiple myeloma after autologous stem cell transplantation.
Idecabtagene vicleucel is being studied in multiple myeloma, specifically in adult patients with newly diagnosed disease who have a suboptimal response after autologous stem cell transplantation. The Phase 3 trial compares it combined with lenalidomide maintenance therapy against lenalidomide maintenance therapy alone.
Idecabtagene vicleucel targets TNFRSF17, also known as BCMA, a protein expressed on the surface of myeloma cells. It is a binding agent designed to direct CAR-T cells toward cells carrying this target. The molecular target is TNFRSF17, classified as a binding agent target.
Idecabtagene vicleucel is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is running the Phase 3 clinical program evaluating the therapy in multiple myeloma.
Idecabtagene vicleucel is in Phase 3 clinical development. It is an investigational therapy and is not described as approved. The ongoing Phase 3 study is active but not recruiting, and no completed trials are listed for this asset.
Idecabtagene vicleucel is being evaluated in the Phase 3 trial NCT06045806, which compares it with lenalidomide maintenance therapy versus lenalidomide maintenance therapy alone in adults with newly diagnosed multiple myeloma who have a suboptimal response after autologous stem cell transplantation. The trial is active but not recruiting and has enrolled 79 participants across 18 countries.