Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ide-cel, BMS-986395, Nonconforming idecabtagene vicleucel, idecabtagene vicleucel, Abecma
bb2121 · 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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bb2121 is being developed for the treatment of multiple myeloma, a cancer of plasma cells in the bone marrow. It has been studied in relapsed and refractory multiple myeloma as well as in high-risk, newly diagnosed multiple myeloma. It is an investigational therapy and is not approved for commercial use.
bb2121 targets BCMA, or B-cell maturation antigen, which is expressed on the surface of multiple myeloma cells. By binding BCMA, bb2121 directs an immune response against those cells. BCMA is a validated antigen in multiple myeloma, and bb2121 is designed to exploit that target selectively.
bb2121 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. Bristol-Myers Squibb holds the development program for bb2121 across its multiple myeloma clinical studies.
bb2121 has completed Phase 3 clinical development. The Phase 3 study, NCT03651128, evaluated bb2121 against standard regimens in relapsed and refractory multiple myeloma and has been completed. bb2121 remains an investigational agent and is not approved by the FDA.
bb2121 has been studied in five completed clinical trials. These include the Phase 3 trial NCT03651128, the Phase 2 trials NCT03601078 and NCT03361748, and the Phase 1 trial NCT04196491 in newly diagnosed multiple myeloma. Total enrollment across these studies was 927 participants.
Yes. bb2121 has been evaluated in high-risk, newly diagnosed multiple myeloma in the Phase 1 study NCT04196491, which enrolled 13 participants in the United States. The larger studies, including the Phase 3 trial NCT03651128, focused on relapsed and refractory multiple myeloma.