Multiple Myeloma

Multiple Myeloma

Multiple Myeloma

References

  1. National Comprehensive Cancer Network®. NCCN Clinical Practice Guidelines in Oncology. Multiple Myeloma. Version 5.2022. Published March 9, 2022. https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf
  2. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. doi:10.3322/caac.21708
  3. Ding H, Xu J, Lin Z, et al. Minimal residual disease in multiple myeloma: Current status. Biomark Res. 2021;9(1):75. doi:10.1186/s40364-021-00328-2
  4. Raje NS, Anaissie E, Kumar SK, et al. Consensus guidelines and recommendations for infection prevention in multiple myeloma: A report from the International Myeloma Working Group. Lancet Haematol. 2022;9(2):e143-e161. doi:10.1016/S2352-3026(21)00283-0
  5. Zhang Z, Liu X, Zhao L, et al. A review on the treatment of multiple myeloma with small molecular agents in the past five years. Eur J Med Chem. 2022;229:114053. doi:10.1016/j.ejmech.2021.114053
  6. Yang Y, Li Y, Gu H, Dong M, Cai Z. Emerging agents and regimens for multiple myeloma. J Hematol Oncol. 2020;13(1):150. doi:10.1186/s13045-020-00980-5
  7. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331. doi:10.1056/NEJMoa1607751
  8. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(8):754-766. doi:10.1056/NEJMoa1606038
  9. Facon T, Kumar SK, Plesner T, et al. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): Overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(11):1582-1596. doi:10.1016/S1470-2045(21)00466-6
  10. Bringhen S, Pour L, Vorobyev V, et al. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis. Leuk Res. 2021;104:106576. doi:10.1016/j.leukres.2021.106576
  11. Grosicki S, Simonova M, Spicka I, et al. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): A randomised, open-label, phase 3 trial. Lancet. 2020;396(10262):1563-1573. doi:10.1016/S0140-6736(20)32292-3
  12. Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015;373(7):621-631. doi:10.1056/NEJMoa1505654
  13. Kleber M, Ntanasis-Stathopoulos I, Terpos E. BCMA in multiple myeloma-A promising key to therapy. J Clin Med. 2021;10(18):4088. doi:10.3390/jcm10184088
  14. Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): A two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020;21(2):207-221. doi:10.1016/S1470-2045(19)30788-0
  15. Munshi NC, Anderson LD Jr, Shah N, et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med. 2021;384(8):705-716. doi:10.1056/NEJMoa2024850
  16. US Food & Drug Administration (FDA). FDA approves idecabtagene vicleucel for multiple myeloma. Published March 26, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-idecabtagene-vicleucel-multiple-myeloma
  17. Berdeja JG, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): A phase 1b/2 open-label study. Lancet. 2021;398(10297):314-324. doi:10.1016/S0140-6736(21)00933-8
  18. US Food & Drug Administration (FDA). FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma. Published February 28, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma
  19. National Institutes of Health (NIH). National Cancer Institute. FDA approves BCMA-targeted CAR T-cell therapy for multiple myeloma. Published April 14, 2021. https://www.cancer.gov/news-events/cancer-currents-blog/2021/fda-ide-cel-car-t-multiple-myeloma
  20. Lancman G, Richter J, Chari A. Bispecifics, trispecifics, and other novel immune treatments in myeloma. Hematology Am Soc Hematol Educ Program. 2020;2020(1):264-271. doi:10.1182/hematology.2020000110
  21. Cho SF, Xing L, Anderson KC, Tai YT. Promising antigens for the new frontier of targeted immunotherapy in multiple myeloma. Cancers (Basel). 2021;13(23):6136. doi:10.3390/cancers13236136
  22. Verkleij CPM, Frerichs KA, Broekmans M, et al. T-cell redirecting bispecific antibodies targeting BCMA for the treatment of multiple myeloma. Oncotarget. 2020;11(45):4076-4081. Published 2020 Nov 10. doi:10.18632/oncotarget.27792
  23. Zonder JA, Richter J, Bumma N, et al. Early, deep, and durable responses, and low rates of CRS with REGN5458, a BCMAxCD3 bispecific monoclonal antibody, in a phase 1/2 first-in-human study in patients with relapsed/refractory multiple myeloma. HemaSphere. 2022;6:90-91 doi:10.1097/01.HS9.0000843648.44771.79
  24. Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;387(6):495-505. doi:10.1056/NEJMoa2203478
  25. Costa LJ, Wong SW, Bermúdez A, et al. First Clinical Study of the B-Cell Maturation Antigen (BCMA) 2+1 T Cell Engager (TCE) CC-93269 in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Interim Results of a Phase 1 Multicenter Trial. Blood. 2019;134(Suppl 1):143. https://ashpublications.org/blood/article/134/Supplement_1/143/426168/First-Clinical-Study-of-the-B-Cell-Maturation
  26. Bahlis NJ, Raje NS, Costello C, et al. Efficacy and safety of elranatamab (PF-06863135), a B-cell maturation antigen (BCMA)-CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MM). Journal of Clinical Oncology. https://ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.8006. Published May 28, 2021.
  27. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/results?cond=Multiple+Myeloma&term=bispecific&cntry=&state=&city=&dist=. Accessed September 2022.

Clinical Toolkit

Burden, Assessment, and Available Therapeutics in MM

Therapeutic Antibodies in Clinical Development

Ongoing Clinical Trials With Bispecific Antibodies

AVAHO

References

This activity is provided by Med Learning Group.
This activity is supported by an independent medical education grant from Regeneron Pharmaceuticals, Inc.
Copyright © 2024 Med Learning Group. Built by Divigner. All Rights Reserved.

Scroll to Top
Home
Clinical Toolkit
Burden, Assessment, and Available Therapeutics in Multiple Myeloma
Therapeutic Antibodies in Clinical Development
Ongoing Clinical Trials With Bispecific Antibodies
References
Patient Toolkit
What is Multiple Myeloma?
What are Antibody Therapies?
Living with Multiple Myeloma
FAQ
Resources
Can We Talk?
CME Activities
Animations
About Us
Contact
Note: This CME program was recorded prior to the American Society of Clinical Oncology (ASCO) 2023 meeting in June 2023. Highlights of data released at ASCO include:

Teclistamab

Longer-term data of the Phase 1/2 MajesTEC-1 study showed a high rate of deep and durable response in triple-class exposed MM patients. At 22 median follow up; complete response or better = 43%; duration of response = 24 months (27 months for ≥CR); median PFS = 12.5 months (20 months for ≥CR); median OS = 21.9 months (not reached for ≥CR).

Adverse event profile for all patients (and grade 3/4) included: infections = 78% (52%); CRS = 72% (0.6%); neutropenia = 72% (65%); anemia = 54% (38%); thrombocytopenia = 42% (22%); and lymphopenia = 35% (33%). ICANS occurred in 3% of patients, all grade 1 or 2.

Reference: van de Donk NWCJ, et al. Long-term follow-up from MajesTEC-1 of teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM). J Clin Oncol. 2023;41(suppl 16):8011. doi:10.1200/JCO.2023.41.16_suppl.8011

Linvoseltamab (investigational)

Two Phase 2 full dose cohorts (50 mg and 200 mg) in the LINKER-MM1 trial were studied to optimize dose selection. Linvoseltamab 200 mg showed better efficacy compared with 50 mg, including in patients with high disease burden. The 200 mg dose had consistent efficacy across high-risk subgroups and induced responses in pts who progressed on 50 mg. The recommended dose for further study is now 200mg.

ORR for 200 mg dose = 71%; CR = 30%; very good partial response = 59%. Median duration of response = not reached. The probability of maintaining response at 6 months was 84% and 79% at 12 months. Treatment-emergent adverse events were reported in 95% of patients (grade 3 or higher = 79%): CRS = 45% (1%); neutropenia = 33%; fatigue = 33%; anemia = 27% (24%). ICANS ≥grade 3 = 2%.

References:

Lee HC, et al. LINKER-MM1 study: Linvoseltamab (REGN5458) in patients with relapsed/refractory multiple myeloma. J Clin Oncol. 2023;41(suppl 16):8006. doi:10.1200/JCO.2023.41.16_suppl.8006

Updated Linvoseltamab (BCMAxCD3) Data from pivotal trial demonstrates early, deep, and durable responses in patients with heavily pre-treated multiple myeloma. News release. Regeneron Pharmaceuticals, Inc; May 25, 2025. Accessed June 15, 2023. https://investor.regeneron.com/news-releases/news-release-details/updated-linvoseltamab-bcmaxcd3-data-pivotal-trial-demonstrates

Elranatamab (investigational)

Pooled data from the MagnetismMM studies were presented. In pts with RRMM and prior exposure to BCMA-directed therapies, elranatamab was efficacious and well tolerated; no new safety signals were observed vs the BCMA-naïve population. ORR = 45.3% (prior anti-BCMA therapy = 41%-53%); median time to OR = 1.9 months; complete response or better = 17.4%; duration of response at 9 months = 72% (prior anti-BCMA therapy = 67.3%-78%); median PFS = 4.8 months; median OS 10-month endpoint not reached, but = 60.1% at 9 months.

Treatment-emergent adverse events in all patients (and grade 3 or higher) included: CRS = 65% (1%); anemia = 59% (47%); neutropenia = 44% (41%); thrombocytopenia = 41% (29%); diarrhea = 34% (0%); lymphopenia = 33% (30%); and ICANS = 6% (2%).

Reference: Nooka AK, et al. Efficacy and safety of elranatamab in patients with relapsed/refractory multiple myeloma (RRMM) and prior B-cell maturation antigen (BCMA)-directed therapies: A pooled analysis from MagnetisMM studies. J Clin Oncol. 2023;41(16 suppl):8008. doi:10.1200/JCO.2023.41.16_suppl.8008