INDICATION

ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

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ABECMA® Information and Resources for Nurses

As a nurse, you play a critical role in the ABECMA treatment process, helping RRMM patients navigate their journey with ABECMA. Get the information and tools you need to help support your patients below.

From clinical trial data to monitoring and management information, it’s all here—so you can continue to help your patients feel comfortable and secure throughout their treatment journey.

RRMM=relapsed/refractory multiple myeloma.

ABECMA: Proven CAR T Cell Therapy Power in the Patients You’re Likely to See1

With durable efficacy data and the most real-world experience of any CAR T cell therapy in RRMM, ABECMA may help your patients focus on their freedom after a one-time infusion.

Rapid, deep, and durable responses with ABECMA1-4*

Survival at 24-month follow-up analysis

mPFS

11.1

MONTHS

(95% CI, 6.08-12.22)

mOS

24.0

MONTHS

(95% CI, 18.96-NE)

OS was a secondary endpoint of KarMMa and was not statistically tested in the setting of a single-arm trial. OS data are not in the USPI and should be interpreted with caution in a single-arm trial. The statistical significance of OS is not known. Median follow-up of 19.9 months (range 0.2-31.5): 50 events and 50 deaths occurred prior to data cutoff December 2020.

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A majority of patients responded to ABECMA, with more than half achieving ≥VGPR.

ABECMA was studied in the largest pivotal study, with more real-world experience than any other CAR T cell therapy in MM1,5,6§

KarMMa was an open-label, single-arm, multicenter trial that evaluated the efficacy and safety of ABECMA in adult patients with RRMM who had received at least 3 prior antimyeloma therapies, including an IMiD® agent, a PI, and an anti-CD38 monoclonal antibody. The primary endpoint was ORR (PR or better as assessed by an IRC). Select secondary endpoints included CR, DoR, MRD, OS, PFS, TTR, and safety. Of the 135 patients who underwent leukapheresis, 100 (74%) received ABECMA in the dose range of 300 to 460 x 106 CAR-positive T cells. ABECMA is an autologous product; the manufactured dose for individual patients may vary. The study consisted of pretreatment (leukapheresis and bridging therapy|| [if needed]); treatment (LDC and ABECMA infusion); and post-treatment monitoring. The LDC consisted of cyclophosphamide (300 mg/m2 IV infusion daily for 3 days) and fludarabine (30 mg/m2 IV infusion daily for 3 days) starting 5 days prior to the target infusion date of ABECMA.1,4

Focus on your patients’ freedom after a one-time infusion of ABECMA

While regular check-ins with their healthcare team are still required, the following are NOT required for patients while they are responding to ABECMA1:

No repeated infusions icon

Repeated infusions

No maintenance therapy icon

Maintenance therapy

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Daily pills

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Efficacy data based on long-term follow-up analysis (median time from ABECMA infusion to data cutoff 27.3 months [range: 24.1 to 33.1]; N=100). Data were generally consistent with the primary analysis.

Response is defined as achieving ≥PR. Of the 100 patients in the efficacy-evaluable population, 25 (25%) achieved a VGPR (95% CI, 16.5-33.5) and 18 (18%) achieved a PR (95% CI, 10.5-25.5).7

All complete responses were sCRs.

Defined as being in market since 2021 as the first CAR T cell therapy in RRMM.

Bridging therapy with alkylating agents, corticosteroids, immunomodulatory agents, proteasome inhibitors, and/or anti-CD38 monoclonal antibodies to which patients were previously exposed was permitted for disease control between apheresis and until 14 days before the start of lymphodepleting chemotherapy.

Per the study protocol, patients were monitored at the treatment center for 14 days after ABECMA infusion for potential cytokine release syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and neurotoxicity.

CAR=chimeric antigen receptor; CR=complete response; DoR=duration of response; IRC=Independent Response committee; IV=intravenous; LDC=lymphodepleting chemotherapy; mDoR=median duration of response; MM=multiple myeloma; mOS=median overall survival; MRD=minimal residual disease; mTTR=median time to response; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PI=proteasome inhibitor; PR=partial response; TTR=time to response; sCR=stringent complete response; VGPR=very good partial response.

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INDICATION

ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
  • Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
  • Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
  • ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.

Warnings and Precautions:
Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA in 85% (108/127) of patients. Grade 3 or higher CRS occurred in 9% (12/127) of patients, with Grade 5 CRS reported in one (0.8%) patient. The median time to onset of CRS, any grade, was 1 day (range: 1 – 23 days) and the median duration of CRS was 7 days (range: 1 – 63 days). The most common manifestations included pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and headache. Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress syndrome (ARDS), atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome, and HLH/MAS.

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Fifty four percent (68/127) of patients received tocilizumab (single dose: 35%; more than 1 dose: 18%). Overall, 15% (19/127) of patients received at least 1 dose of corticosteroids for treatment of CRS. All patients that received corticosteroids for CRS received tocilizumab. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of CRS and monitor patients for signs or symptoms of CRS for at least 4 weeks after ABECMA infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated.

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Neurologic Toxicities: Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA in 28% (36/127) of patients receiving ABECMA, including Grade 3 in 4% (5/127) of patients. One patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff. The median time to onset of neurotoxicity was 2 days (range: 1 – 42 days). CAR T cell-associated neurotoxicity resolved in 92% (33/36) of patients with a median time to resolution of 5 days (range: 1 – 61 days). The median duration of neurotoxicity was 6 days (range: 1 – 578) in all patients including 3 patients with ongoing neurotoxicity. Thirty-four patients with neurotoxicity had CRS with onset in 3 patients before, 29 patients during, and 2 patients after CRS. The most frequently reported manifestations of CAR T cell-associated neurotoxicity include encephalopathy, tremor, aphasia, and delirium. Grade 4 neurotoxicity and cerebral edema in 1 patient, Grade 3 myelitis, and Grade 3 parkinsonism have been reported with ABECMA in another study in multiple myeloma.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of neurologic toxicities and monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed.

Counsel patients to seek immediate medical attention should signs or symptoms occur at any time.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of patients receiving ABECMA. One patient developed fatal multi-organ HLH/MAS with CRS and another patient developed fatal bronchopulmonary aspergillosis with contributory HLH/MAS. Three cases of Grade 2 HLH/MAS resolved. All events of HLH/MAS had onset within 10 days of receiving ABECMA with a median onset of 7 days (range: 4 – 9 days) and occurred in the setting of ongoing or worsening CRS. Two patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction, and cytopenia. HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines.

ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or 1-888-423-5436.

Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.

Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion. Infections (all grades) occurred in 70% of patients. Grade 3 or 4 infections occurred in 23% of patients. Overall, 4 patients had Grade 5 infections (3%); 2 patients (1.6%) had Grade 5 events of pneumonia, 1 patient (0.8%) had Grade 5 bronchopulmonary aspergillosis, and 1 patient (0.8%) had cytomegalovirus (CMV) pneumonia associated with Pneumocystis jirovecii. Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines.

Febrile neutropenia was observed in 16% (20/127) of patients after ABECMA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care.

Viral Reactivation: CMV infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: In the clinical study, 41% of patients (52/127) experienced prolonged Grade 3 or 4 neutropenia and 49% (62/127) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 83% (43/52) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 65% (40/62) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 2.1 months.

Three patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. Two of the three patients died from complications of prolonged cytopenia. Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support.

Hypogammaglobulinemia: Hypogammaglobulinemia was reported as an adverse event in 21% (27/127) of patients; laboratory IgG levels fell below 500 mg/dl after infusion in 25% (32/127) of patients treated with ABECMA.

Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA.

Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 to obtain instructions on patient samples to collect for testing of secondary malignancy of T cell origin.

Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, patients receiving ABECMA are at risk for altered or decreased consciousness or coordination in the 8 weeks following ABECMA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Adverse Reactions: The most common nonlaboratory adverse reactions include CRS, infections – pathogen unspecified, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

References: 1. ABECMA [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2021. 2. Data on file. BMS-REF-IDC-0002. Princeton, NJ: Bristol-Myers Squibb Company; 2021. 3. Data on file. IDEC 009. Princeton, NJ: Bristol-Myers Squibb Company; 2021. 4. Munshi NC, Anderson LD Jr, Shah N, et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. [Protocol BB2121-MM-001]. N Engl J Med. 2021;384(8):1-1012. 5. A study of JNJ-68284528, a chimeric antigen receptor T Cell (CAR-T) therapy directed against B-cell maturation antigen (BCMA) in participants with relapsed or refractory multiple myeloma (CARTITUDE-1). ClinicalTrials.gov identifier: NCT03548207. Updated June 21, 2022. Accessed July 12, 2022. https://clinicaltrials.gov/ct2/show/NCT03548207 6. Efficacy and safety study of bb2121 in subjects with relapsed and refractory multiple myeloma (KarMMa). ClinicalTrials.gov identifier: NCT03361748. Updated August 6, 2021. Accessed July 12, 2022. https://clinicaltrials.gov/ct2/show/NCT03361748 7. Data on file. BMS-REF-IDC-0018. Princeton, NJ: Bristol-Myers Squibb Company; 2021.

References: 1. ABECMA [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2021. 2. Data on file. BMS-REF-IDC-0002. Princeton, NJ: Bristol-Myers Squibb Company; 2021. 3. Data on file. IDEC 009. Princeton, NJ: Bristol-Myers Squibb Company; 2021. 4. Munshi NC, Anderson LD Jr, Shah N, et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. [Protocol BB2121-MM-001]. N Engl J Med. 2021;384(8):1-1012. 5. A study of JNJ-68284528, a chimeric antigen receptor T Cell (CAR-T) therapy directed against B-cell maturation antigen (BCMA) in participants with relapsed or refractory multiple myeloma (CARTITUDE-1). ClinicalTrials.gov identifier: NCT03548207. Updated June 21, 2022. Accessed July 12, 2022. https://clinicaltrials.gov/ct2/show/NCT03548207 6. Efficacy and safety study of bb2121 in subjects with relapsed and refractory multiple myeloma (KarMMa). ClinicalTrials.gov identifier: NCT03361748. Updated August 6, 2021. Accessed July 12, 2022. https://clinicaltrials.gov/ct2/show/NCT03361748 7. Data on file. BMS-REF-IDC-0018. Princeton, NJ: Bristol-Myers Squibb Company; 2021.