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 two 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

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

From the treatment process to adverse event monitoring and management information, it’s here—so you can continue to guide your patients throughout their treatment journey.

RRMM=relapsed/refractory multiple myeloma.

Depend on the ABECMA Treatment Process—Backed by Extensive Real-world Experience in RRMM1*

What freedom could mean after a one-time infusion1† of ABECMA

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

No Repeated Infusions Icon

Repeated infusions

No Maintenance Therapy Icon

Maintenance therapy

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Daily pills

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

Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring. A single dose of ABECMA contains a cell suspension of 300 to 510 x 106 CAR-positive T cells in one or more infusion bags.

Help your patients understand the ABECMA treatment process and the care team they may encounter throughout their journey

The ABECMA treatment journey requires close collaboration between a patient's primary oncologist and a certified ABECMA treatment center.

The Learn How ABECMA Is Made video can help your patients understand the ABECMA manufacturing process

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The Meet your ABECMA Care Team video can help educate your patients on the trained professionals they may encounter

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Meet your ABECMA® CAR T Care Team Video Thumbnail
SEE ABECMA RESOURCES

The ABECMA treatment process

See a summary of select steps of the ABECMA treatment process below.

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See the ABECMA Clinician Guide

for a detailed overview of the ABECMA treatment process.

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  • Patient eligibility and initiation1

    • Eligible adult patients include those who are triple-class exposed (patients who have received an IMiD® agent, a PI, and an anti-CD38 monoclonal antibody) and who have received at least 2 prior lines of therapy

  • Leukapheresis1,2

    • T cells are collected via leukapheresis

  • Manufacturing1

    • The patient’s cells are sent to a manufacturing site for engineering and expansion to the recommended dose
    • ABECMA is an autologous product; the manufactured dose for individual patients may vary
    • The patient’s recommended dose is 300 to 510 x 106 CAR-positive T cells
    • Bridging therapy can be used in some patients at the physician's discretion for disease control during the manufacturing process

    94%

    commercial manufacturing success rate2‡

  • Shipping and receipt4

    • To ensure patient safety, Bristol Myers Squibb requires chain of identity (COI) at 4 key points in the treatment process: when receiving the LN2 dry vapor shipper; after transferring ABECMA to on-site storage; prior to thawing ABECMA; and prior to ABECMA administration
    • On the scheduled date, ABECMA will be shipped directly to the infusion site’s assigned address and/or department, as specified on the Cell Therapy 360® Scheduling Portal
    • Cryopreserved ABECMA will be shipped to the treatment site in a LN2 dry vapor shipper

  • Storage4

    • The method of storage will depend on the individual site's capabilities: just-in-time delivery (ABECMA arrives on or near the date of infusion and remains in the LN2 dry vapor shipper until the product is thawed for patient administration) or on-site storage by preapproved process (ABECMA is transferred to on-site vapor-phase LN2 storage)

  • Lymphodepleting chemotherapy1,2

    • Begin administration of lymphodepleting chemotherapy 5 days before the patient’s scheduled ABECMA infusion (fludarabine [30 mg/m2 IV infusion] and cyclophosphamide [300 mg/m2 IV infusion] daily for 3 days)
    • The care team is notified of the estimated ABECMA delivery date. Product availability should be confirmed prior to starting lymphodepletion
    • Across registrational studies, MM bridging therapies (following leukapheresis) were stopped ≥14 days prior to lymphodepleting chemotherapy

  • Premedication1

    • Approximately 30 to 60 minutes before ABECMA infusion, administer acetaminophen (650 mg orally) and diphenhydramine (12.5 mg IV or 25 to 50 mg orally, or another H1-antihistamine). Avoid prophylactic use of dexamethasone or other systemic corticosteroids, as they may interfere with the activity of ABECMA

  • Thawing4

    • Each infusion bag must be infused within 1 hour of the start of its thaw
    • See the ABECMA Clinician Guide for detailed instructions on thawing ABECMA infusion bags

  • Infusion1,4

    • Administer ABECMA 2 days after the patient completes lymphodepletion
      • Step 1: Infuse the contents of the infusion bag by gravity flow
      • Step 2: After the entire contents of the infusion bag have been infused, flush the tubing with 30 to 60 mL of normal saline at the same infusion rate to ensure all the cells are delivered
      • Step 3: If more than 1 infusion bag is being administered, repeat the procedure (thawing through saline flush) to administer subsequent infusion bags of ABECMA in series
        • Keep the remaining bag(s) in LN2 storage until prior bag has been infused and patient is ready; proceed to the subsequent infusion bag based on clinical judgment
    • Delay the infusion of ABECMA up to 7 days if a patient has any of the following: unresolved serious adverse events (especially pulmonary events, cardiac events, or hypotension), including those after preceding chemotherapies, active infections, or inflammatory disorders
    • ABECMA is provided as a single dose for infusion containing a suspension of CAR-positive T cells in 1 or more infusion bags

WEEKS 1-4

FIRST 7 DAYS AFTER INFUSION

Monitoring at the treatment center

  • The care team will monitor patients for signs and symptoms of CRS and neurologic toxicity at least daily for 7 days following infusion at the REMS-certified healthcare facility
  • Treat at the first sign of CRS or neurologic toxicity as needed based on the grading and management guidelines

Treatment center staff will work together to manage and treat any symptoms that may arise.

WEEKS 2-4

Patients should be instructed to stay within 2 hours of the certified healthcare facility for at least 4 weeks after infusion.

Topics to discuss with your patient and their caregiver
  • Alerting their healthcare provider or getting emergency help right away if they have symptoms of CRS or neurologic toxicity
  • Attending appointments at the treatment center
  • Refraining from driving or hazardous activities for at least 8 weeks following infusion
Topics to discuss with your patient's caregiver
  • Calling the ABECMA care team if the patient experiences any symptoms
  • Taking the patient to scheduled appointments at the treatment center

WEEK 4+

AFTER AT LEAST 4 WEEKS OF MONITORING

Long-term monitoring

  • Patients should remain within proximity of the certified healthcare facility for at least 4 weeks following infusion for monitoring
  • After at least 4 weeks of monitoring, your patient may return to their primary oncologist for continued monitoring and routine care appointments
  • Patients treated with ABECMA may develop secondary malignancies. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing of secondary malignancy of T cell origin

Lots manufactured between January 2023-November 2023. Manufacturing success rate is calculated as patients successfully treated with conforming product/patients apheresed.

CAR=chimeric antigen receptor; CRS=cytokine release syndrome; IV=intravenous; LN2=liquid nitrogen; MM=multiple myeloma; PI=proteasome inhibitor; REMS=Risk Evaluation and Mitigation Strategy.

Learn more about
ABECMA
efficacy

SEE TRIAL RESULTS

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safety
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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 two 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, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES

  • 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.
  • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA
  • ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.

Warnings and Precautions:
Early Death: In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254; 18%) compared to the standard regimens arm (15/132; 11%). Early deaths occurred in 8% (20/254) and 0% prior to ABECMA infusion and standard regimen administration, respectively, and 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen administration, respectively. Out of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events and 2 occurred from unknown causes. Out of the 25 deaths that occurred after ABECMA infusion, 10 occurred from disease progression, 11 occurred from adverse events, and 4 occurred from unknown causes.

Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in 89% (310/349), including ≥ Grade 3 CRS (Lee grading system) in 7% (23/349) of patients and Grade 5 CRS in 0.9% (3/349) of patients. The median time-to-onset of CRS, any grade, was 1 day (range: 1 to 27 days), and the median duration of CRS was 5 days (range: 1 to 63 days). In the pooled studies, the rate of ≥Grade 3 CRS was 10% (7/71) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 5.4% (13/241) for patients treated in dose range of 300 to 460 x 106 CAR-positive T cells.

The most common manifestations of CRS (greater than or equal to 10%) included pyrexia (87%), hypotension (30%), tachycardia (26%), chills (19%), hypoxia (16%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, coagulopathy, renal failure, 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. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Overall, 24% (82/349) of patients received at least 1 dose of corticosteroids for treatment of CRS. Almost all patients who received corticosteroids for CRS also received tocilizumab. For patients treated in dose range of 460 to 510 x 106 CAR-positive T cells, 76% (54/71) of patients received tocilizumab and 35% (25/71) received at least 1 dose of corticosteroids for treatment of CRS. For patients treated in dose range of 300 to 460 x 106 CAR-positive T cells, 63% (152/241) of patients received tocilizumab and 20% (49/241) received at least 1 dose of corticosteroid for treatment of CRS.

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. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Neurologic Toxicities: Neurologic toxicities, including immune-effector cell-associated neurotoxicity (ICANS), which may be severe or life-threatening, occurred concurrently with CRS, after CRS resolution, or in the absence of CRS following treatment with ABECMA.

In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, CAR T cell-associated neurotoxicity occurred in 40% (139/349), including Grade 3 in 4% (14/349) and Grade 4 in 0.6% (2/349) of patients. The median time to onset of neurotoxicity was 2 days (range: 1 to 148 days). The median duration of CAR T cell-associated neurotoxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cut off. CAR T cell-associated neurotoxicity resolved in 123 of 139 (88%) patients and median time to resolution was 5 days (range: 1 to 245 days). One-hundred and thirty four out of 349 (38%) patients with neurotoxicity had CRS. The onset of neurotoxicity during CRS was observed in 93 patients, before the onset of CRS in 12 patients, and after the CRS event in 29 patients. The rate of Grade 3 or 4 CAR T cell-associated neurotoxicity was 5.6% (4/71) and 3.7% (9/241) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 300 to 460 x 106 CAR-positive T cells, respectively. The most frequent (greater than or equal to 5%) manifestations of CAR T cell-associated neurotoxicity include encephalopathy (21%), headache (15%), dizziness (8%), delirium (6%), and tremor (6%).

At the safety update for KarMMa-3 study, one patient developed fatal neurotoxicity 43 days after ABECMA. In KarMMa, 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.

Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment 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): In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, HLH/MAS occurred in 2.9% (10/349) of patients. All events of HLH/MAS had onset within 10 days of receiving ABECMA, with a median onset of 6.5 days (range: 4 to 10 days) and occurred in the setting of ongoing or worsening CRS. Five patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction and cytopenia.

In KarMMa-3, one patient had Grade 5, two patients had Grade 4 and two patients had Grade 3 HLH/MAS. The patient with Grade 5 HLH/MAS also had Grade 5 candida sepsis and Grade 5 CRS. In another patient who died due to stroke, the Grade 4 HLH/MAS had resolved prior to death. Two cases of Grade 3 and one case of Grade 4 HLH/MAS had resolved.

In KarMMa, one patient treated in the 300 x 106 CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved.

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 contact Bristol-Myers Squibb at 1-866-340-7332.

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.

In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, infections (all grades) occurred in 61% of patients. Grade 3 or 4 infections occurred in 21% of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 7%, bacterial infections in 4.3%, and fungal infections in 1.4% of patients. Overall, 15 patients had Grade 5 infections (4.3%); 8 patients (2.3%) with infections of pathogen unspecified, 3 patients (0.9%) with fungal infections, 3 patients (0.9%) with viral infections, and 1 patient (0.3%) with bacterial infection.

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 38% (133/349) 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 as medically indicated.

Viral Reactivation: Cytomegalovirus (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. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.

Prolonged Cytopenias: In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, 40% of patients (139/349) experienced prolonged Grade 3 or 4 neutropenia and 42% (145/349) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 89% (123/139) 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 76% (110/145) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 1.9 months. Five patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. The rate of Grade 3 or 4 thrombocytopenia was 62% (44/71) and 56% (135/241) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 300 to 460 x 106 CAR-positive T cells, respectively.

Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines.

Hypogammaglobulinemia: In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, hypogammaglobulinemia was reported as an adverse event in 13% (46/349) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 37% (130/349) of patients treated with ABECMA.

Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 45% (158/349) of patients treated with ABECMA. Forty-one percent of patients received intravenous immunoglobulin (IVIG) post-ABECMA for serum IgG <400 mg/dL.

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.

Use of Live Vaccines: 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. In KarMMa-3, myeloid neoplasms (four cases of myelodysplastic syndrome and one case of acute myeloid leukemia) occurred in 2.2% (5/222) of patients following treatment with ABECMA compared to none in the standard regimens arm at the time of the safety update. The median time to onset of myeloid neoplasm from ide-cel infusion was 338 days (Range: 277 to 794 days). Three of these five patients have died following the development of myeloid neoplasm. One out of the five cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy.

T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.

Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing of secondary malignancy.

Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, including altered mental status or seizures, 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 (incidence greater than or equal to 20%) include pyrexia, CRS, hypogammaglobulinemia, infections – pathogen unspecified, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea and viral infections.

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

References:
1. ABECMA [package insert], Summit, NJ: Bristol-Myers Squibb Company; 2024. 2. Data on file. US cell therapy operational talking points & FAQs. Princeton, NJ: Bristol-Myers Squibb Company; Feb 2024.

References:
1. ABECMA [package insert], Summit, NJ: Bristol-Myers Squibb Company; 2024. 2. Data on file. US cell therapy operational talking points & FAQs. Princeton, NJ: Bristol-Myers Squibb Company; Feb 2024.