This document summarizes BCMA antibody and CAR-T cell therapies for multiple myeloma. It provides regulatory status, dosing details, and safety considerations for four BCMA antibody therapies - elranatamab, linvoseltamab, teclistamab, and ABBV-383. It also reviews dosing ranges and general safety principles for the two FDA-approved CAR-T cell therapies ciltacabtagene autoleucel and idecabtagene vicleucel. Both CAR-T therapies require administration through a Risk Evaluation and Mitigation Strategy program due to risks of cytokine release syndrome and neurologic toxicities.

1. BCMA Antibody Therapy in Multiple Myeloma
Current Status, Dosing, and Practical Considerations
Full abbreviations, accreditation, and disclosure information available at PeerView.com/FNM40
a
Currently available under accelerated approval.
1. D'Souza A et al. J Clin Oncol. 2022;40:3576-3586. 2. https://clinicaltrials.gov/ct2/show/NCT04649359. 3. Lesokhin A et al. ASCO 2022. Abstract 8006. 4. Zonder JA et al. EHA 2022. Abstract S189. 5. https://clinicaltrials.gov/ct2/show/NCT05137054. 6. Tecvayli (teclistamab-cqyv)
Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf. 7. Moreau P et al. ASH 2021. Abstract 896.
REGULATORY STATUS
Phase 2 study in patients with
RRMM and no prior BCMA-targeted
treatment2
Phase 1/2 study in patients with
RRMM4
FDA-approved in patients with RRMM
who have received ≥4 lines of prior
therapy, including an IMiD,
a proteasome inhibitor, and an
anti-CD38 antibodya
; also approved
by the European Medicines Agency
(see PI for more information)6
Phase 1 study in patients with RRMM1
DOSE
Patients received 76 mg
weekly with a two-step-up
priming regimen per the
MagnetisMM-3 trial3
In early-phase testing, 9 dose
levels were evaluated: 3, 6,
12, 24, 48, 96, 200, 400, and
800 mg; 16 weekly infusions
were followed by Q2W dosing
until disease progression5
Day 1: 0.06 mg/kg subcutaneous
injection; day 4: 0.3 mg/kg;
day 7: 1.5 mg/kg; followed by
1.5 mg/kg once weekly until PD
or unacceptable toxicity
In early-phase testing, dose
escalation was 0.025-120 mg
and dose expansion was 60 mg1
SELECT CONSIDERATIONS
The most common AEs were
hematologic events and CRS; the
two-step-up priming regimen is
intended to help mitigate the rate and
severity of CRS3
The most common grade 3/4 TEAEs
were hematologic; the most frequent
TEAEs were fatigue and CRS (most
CRS events were grade 1)4
The most common AEs were
hematologic events and CRS. Note:
ICANS events occurred in 4 patients
but were all grade 1/2 and resolved
without discontinuation7
The most common TEAEs were
neutropenia, anemia, CRS, and
fatigue1
THERAPY
Elranatamab
BCMA
x CD3
Linvoseltamab
BCMA
x CD3
Teclistamab
BCMA
x CD3
ABBV-383
BCMA
x CD3
Note 1: Although the BCMA antibody–drug conjugate belamaf received FDA Accelerated Approval in 2020, the manufacturer has initiated the process for
withdrawal of the US marketing authorization based on findings from the DREAMM-3 phase III confirmatory trial.
Note 2: Other bispecific BCMA and non-BCMA agents are also in rapid development, including TNB383b, talquetamab, cevostamab, and HPN217.

2. CAR-T Cell Therapy in Multiple Myeloma
Current Status, Dosing, and Practical Considerations
Full abbreviations, accreditation, and disclosure information available at PeerView.com/FNM40
1. Carvykti (ciltacabtagene autoleucel) Prescribing Information. https://www.fda.gov/media/156560/download. 2. Abecma (idecabtagene vicleucel) Prescribing Information. https://www.fda.gov/media/147055/download.
REMS
Cilta-Cel1
Approved in RRMM after ≥4
prior therapies, including an
anti-CD38 mAb, a proteasome
inhibitor, and an IMiD
Recommended Dose Range
0.5-1.0 × 106
CAR-positive
viable T cells (maximum dose
of 1.0 × 108
CAR-positive
viable T cells per single-dose
infusion)
Recommended Dose Range
300-460 × 106
CAR-positive viable T cells
Ide-Cel2
Approved in RRMM after ≥4
prior therapies, including an
anti-CD38 mAb, a proteasome
inhibitor, and an IMiD
General Principles for CAR-T Therapy
Referral to a certified healthcare facility is required for collection of patient’s cells
and administration of CAR-T therapy
Avoid prophylactic use of dexamethasone or other systemic corticosteroids
Premedicate with acetaminophen and an H1 antihistamine
Monitor for CRS and ICANS and confirm tocilizumab availability before infusion
Ide-cel and cilta-cel are available only through a restricted program under a
Risk Evaluation and Mitigation Strategy (REMS)
Monitor for neurologic events, hemophagocytic lymphohistiocytosis/
macrophage activation syndrome, and cytopenias
Administer a lymphodepleting chemotherapy regimen of cyclophosphamide
and fludarabine before CAR-T infusion
Do not use a leukodepleting filter when administering