Chair & Presenter, Robert Z. Orlowski, MD, PhD, Noa Biran, MD, and Ajay K. Nooka, MD, MPH, FACP, prepared useful Practice Aids pertaining to multiple myeloma for this CME/MOC/AAPA activity titled “The New ABCs of Myeloma Care: Enhancing Outcomes With CD38 Antibodies, BCMA Immunotherapy, and Unique Bispecific Platforms.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at https://bit.ly/3MPq140. CME/MOC/AAPA credit will be available until July 3, 2024.
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The New ABCs of Myeloma Care: Enhancing Outcomes With CD38 Antibodies, BCMA Immunotherapy, and Unique Bispecific Platforms
1. Antibody Therapy in Multiple Myeloma
Current Status, Dosing, and Practical Considerations
Full abbreviations, accreditation, and disclosure information available at PeerView.com/HZN40
Regulatory Status Dosing
Phase 1 study in patients
with RRMM
Phase 2 study in patients
with RRMM and no prior
BCMA-targeted treatment2
• Approved in RRMM in
patients who have received
≥4 lines of prior therapy,
including an IMiD, a PI,
and an anti-CD38 antibody
(FDA); also approved by the
European Medicines Agency
(see PI for more information)
• Day 1: 0.06 mg/kg SC
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
Phase 1/2 study in patients
with RRMM4 200 mg5
Patients received 76 mg
weekly with a two-step-up
priming regimen per the
MagnetisMM-3 trial3
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
In early-phase testing, dose
escalation was 0.025-120
mg and dose expansion
was 60 mg
The most common TEAEs
were neutropenia, anemia,
CRS, and fatigue
Select Considerations
Therapy/Target
Elranatamab
BCMA x CD3
Teclistamab6,a
BCMA x CD3
ABBV-3831
BCMA x CD3
Linvoseltamab
BCMA x CD3
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 3 confirmatory trial
2. Antibody Therapy in Multiple Myeloma
Current Status, Dosing, and Practical Considerations
Full abbreviations, accreditation, and disclosure information available at PeerView.com/HZN40
• Approved in NDMM in
combination with Rd and VMP
in patients who are transplant
ineligible and VTd in patients
who are transplant eligible
• Approved in RRMM in
combination with Rd, Vd, and
pom/dex; as monotherapy
for more heavily pretreated
patients; and in combination with
carfilzomib and dex for patients
who have received 1 to 3 prior
lines of therapy (see PI for more
information)
• Approved in NDMM in
combination with Rd in patients
who are transplant ineligible, in
combination with VMP in patients
who are transplant ineligible, and
in combination with VTd in patients
who are transplant eligible
• Approved in RRMM in combination
with Rd, Vd, Kd, and pom/dex, and
as monotherapy for more heavily
pretreated patients (see PI for more
information)
1,800 mg daratumumab
and 30,000 units
hyaluronidase SC in the
abdomen over ~3 to 5 min
16 mg/kg IV actual
body weight
• Monitor for
- infusion-related reactions
- neutropenia
- thrombocytopenia
• Inform blood banks
• Monitor for hypersensitivity
reactions; screen for hepatitis
B core antibody and surface
antigen prior to initiation and
initiate prophylaxis if needed
• Monitor for
- neutropenia
- thrombocytopenia
• Inform blood banks
• Monitor for hypersensitivity
reactions; screen for hepatitis
B core antibody and surface
antigen prior to initiation and
initiate prophylaxis if needed
Select Considerations
Daratumumab-
hyaluronidase–
fihj9
CD38
Daratumumab8
CD38
Therapy/Target Dosing
Regulatory Status
3. Antibody Therapy in Multiple Myeloma
Current Status, Dosing, and Practical Considerations
Full abbreviations, accreditation, and disclosure information available at PeerView.com/HZN40
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. Bumma N et al. ASH 2022. Abstract 4555. 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. 8. Darzalex (daratumumab) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761036s033lbl.pdf. 9. Faspro
(daratumumab-hyaluronidase–fihj) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf. 10. Sarclisa (isatuximab-irfc) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf.
11. Empliciti (elotuzumab) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761035s008lbl.pdf. 12. Wong SW et al. ASH 2022. Abstract 162.
• Approved in RRMM in
combination with Rd and pom/
dex (see PI for more information)
• Approved in RRMM in
combination with pom/dex
after ≥2 prior therapies,
including lenalidomide and
a PI, and in combination with
carfilzomib and dex for patients
who have received 1 to 3 prior
lines of therapy (see PI for more
information)
• With Rd: 10 mg/kg IV
every wk for 2 cycles and
every 2 wk thereafter
• With pom/dex: 10 mg/kg IV
every wk for 2 cycles and 20
mg/kg every 4 wk thereafter
10 mg/kg IV every wk for
4 wk and every 2 wk
thereafter
• Monitor for
- infusion-related reactions
- neutropenia
- second primary malignancies
- M protein (can affect
determination of CR)
• Monitor CBC periodically during
treatment, and monitor patients
with neutropenia for signs of
infection
• Premedication required for
infusion-related reactions
• Monitor for
- fever and infection
- second primary malignancies
- hepatotoxicity
- M protein (can affect
determination of CR)
Select Considerations
Isatuximab10
CD38
Elotuzumab11
SLAMF7
Other bispecific BCMA and non-BCMA agents are also in rapid development, including TNB383b, talquetamab, cevostamab, and HPN 217
Other new developments: Alnuctamab is an emerging BCMA x CD3 antibody that has demonstrated clinical activity in patients with RRMM who
have been treated with ≥3 prior lines of therapy12
Therapy/Target Dosing
Regulatory Status
4. CAR-T Cell Therapy in Multiple Myeloma
Current Status, Dosing, and Practical Considerations
Full abbreviations, accreditation, and disclosure information available at PeerView.com/HZN40
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
5. Resources for Encouraging Patient Engagement in Care
From HealthTree Foundation for Multiple Myeloma
Full abbreviations, accreditation, and disclosure information available at PeerView.com/HZN40
HealthTree Foundation for Multiple Myeloma offers a wide range of resources that can be used to
encourage patients to learn more about their disease or a planned course of treatment
Patient education and navigation tools
Programs that create patient
connections and build community
A living, real-world evidence data
portal that delivers researchers the
data they need to accelerate a cure
Scan to visit:
healthtree.org/myeloma
Scan to visit:
healthtree.org/myeloma/coach
Free one-on-one help from experienced
patients and caregivers
Help patients get answers
to basic questions about myeloma
Scan to visit:
healthtree.org/myeloma/university
Selected Resources