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CME

Key Studies in Myeloma: CCO Independent Conference Highlights of the 2020 Virtual ASH Annual Meeting

Physicians: Maximum of 1.50 AMA PRA Category 1 Credits™

Released: March 22, 2021

Expiration: March 21, 2022

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References

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  23. US Food and Drug Administration. FDA approves daratumumab and hyaluronidase-fijh for multiple myeloma. Available at: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-daratumumab-and-hyaluronidase-fihj-multiple-myeloma. Accessed March 5, 2021.
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  25. ClinicalTrials.gov. Comparison of pomalidomide and dexamethasone with or without daratumumab in subjects with relapsed or refractory multiple myeloma previously treated with lenalidomide and a proteasome inhibitor/daratumumab/pomalidomide/dexamethasone vs pomalidomide/dexamethasone (EMN14). Available at: https://clinicaltrials.gov/ct2/show/NCT03180736. Accessed March 5, 2021.
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  31. Argueta C, Kashyap T, Klebanov B, et al. Selinexor synergizes with dexamethasone to repress mTORC1 signaling and induce multiple myeloma cell death. Oncotarget. 2018;9:25529-25544.
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  34. Chen CI, Bahlis N, Gasparetto C, et al. Selinexor in combination with pomalidomide and dexamethasone (SPd) for treatment of patients with relapsed refractory multiple myeloma (RRMM). Program and abstracts of the 2020 ASH Annual Meeting and Exposition; December 5-8, 2020. Abstract 726.
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  38. Belantamab mafodotin package insert. Brentford, UK: GlaxoSmithKline; 2020.
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  40. ClinicalTrials.gov. A study to investigate the efficacy and safety of two doses of GSK2857916 in participants with multiple myeloma who have failed prior treatment with an anti-CD38 antibody. Available at: https://clinicaltrials.gov/ct2/show/NCT03525678. Accessed March 5, 2020.
  41. Lonial S, Lee HC, Badros AZ, et al. DREAMM-2: single-agent belantamab mafodotin (belamaf) in patients with relapsed/refractory multiple myeloma (RRMM)—1-year outcomes by prior therapies. Program and abstracts of the 2020 ASH Annual Meeting and Exposition; December 5-8, 2020. Abstract 1417.
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  46. Ghandi AK, Kang J, Havens CG, et al. Immunomodulatory agents lenalidomide and pomalidomide co-stimulate T cells by inducing degradation of T cell repressors Ikaros and Aiolos via modulation of the E3 ubiquitin ligase complex CRL4(CRBN). Br J Haematol. 2014;164:811-821.
  47. Trudel S, McCurdy A, Sutherland HJ, et al. Part 1 results of a dose finding study of belantamab mafodotin (GSK2857916) in combination with pomalidomide (POM) and dexamethasone (DEX) for the treatment of relapsed/refractory multiple myeloma (RRMM). Program and abstracts of the 2020 ASH Annual Meeting and Exposition; December 5-8, 2020. Abstract 725.
  48. ClinicalTrials.gov. Multi-center study of GSK2857916 in combination with pomalidomide and dex. Available at: https://clinicaltrials.gov/ct2/show/NCT03715478. Accessed March 5, 2021.
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  53. Van De Donk NWCJ, Popat R, Larsen J, et al. First results of iberdomide (IBER; CC-220) in combination with dexamethasone (DEX) and daratumumab (DARA) or bortezomib (BORT) in patients with relapsed/refractory multiple myeloma (RRMM). Program and abstracts of the 2020 ASH Annual Meeting and Exposition; December 5-8, 2020. Abstract 724.
  54. ClinicalTrials.gov. A study to determine dose, safety, tolerability and efficacy of CC-220 monotherapy, and in combination with other treatments in subjects with multiple myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT02773030. Accessed March 5, 2021.
  55. Madduri D, Usmani SZ, Jagannath S, et al. Results from CARTITUDE-1: a phase 1b/2 study of JNJ-4528, a CAR-T cell therapy directed against B-cell maturation antigen (BCMA), in patients with relapsed and/or refractory multiple myeloma (R/R MM). Program and abstracts of the 2019 ASH Annual Meeting and Exposition; December 7-10, 2019; Orlando, Florida. Abstract 577.
  56. Madduri D, Berdeja JG, Usmani SZ, et al. CARTITUDE-1: phase 1b/2 study of ciltacabtagene autoleucel, a B-cell maturation antigen–directed chimeric antigen receptor T cell therapy, in relapsed/refractory multiple myeloma. Program and abstracts of the 2020 ASH Annual Meeting and Exposition; December 5-8, 2020. Abstract 177.
  57. ClinicalTrials.gov. A phase 1b-2, open-label study of JNJ-68284528, a chimeric antigen receptor T-cell (CAR-T) therapy directed against BCMA in subjects with relapsed or refractory multiple myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT03548207. Accessed March 5, 2021.
  58. Raje N, Berdeja J, Lin Yi, et al. Anti-BCMA CAR T-cell therapy bb2121 in relapsed or refractory multiple myeloma. N Engl J Med. 2019;380:1726-1737.
  59. Alsina M, Shah N, Raje NS, et al. Updated results from the phase I CRB-402 study of anti-BCMA CAR-T cell therapy bb21217 in patients with relapsed and refractory multiple myeloma: correlation of expansion and duration of response with T Cell phenotypes. Program and abstracts of the 2020 ASH Annual Meeting and Exposition; December 5-8, 2020. Abstract 130.
  60. ClinicalTrials.gov. A phase 1 study of bb21217, an anti-BCMA CAR T cell drug product, in relapsed and/or refractory multiple myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT03274219. Accessed March 5, 2021.
  61. Costello CL, Cohen AD, Patel KK, et al. Phase 1/2 study of the safety and response of P-BCMA-101 CAR-T cells in patients with relapsed/refractory (r/r) multiple myeloma (MM) (PRIME) with novel therapeutic strategies. Program and abstracts of the 2020 ASH Annual Meeting and Exposition; December 5-8, 2020. Abstract 134.
  62. ClinicalTrials.gov. Open-label, multicenter, phase 1 study to assess the safety of P BCMA-101 in subjects with relapsed/refractory multiple myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME). Available at: https://clinicaltrials.gov/ct2/show/NCT03288493. Accessed March 5, 2021.
  63. Mailankody S, Matous JV, Liedtke M, et al. Universal: an allogeneic first-in-human study of the anti-BCMA ALLO-715 and the anti-CD52 ALLO-647 in relapsed/refractory multiple myeloma. Program and abstracts of the 2020 ASH Annual Meeting and Exposition; December 5-8, 2020. Abstract 129.
  64. ClinicalTrials.gov. A single-arm, open-label, phase 1 study of the safety, efficacy, and cellular kinetics/pharmacodynamics of ALLO-715 to evaluate an anti-BCMA allogeneic CAR T cell therapy with or without nirogacestat in subjects with relapsed/refractory multiple myeloma. available at: https://clinicaltrials.gov/ct2/show/nct04093596. accessed march 5, 2021.
  65. Harrison SJ, Minnema MC, Lee HC, et al. A phase 1 first in human (FIH) study of AMG 701, an anti-B-cell maturation antigen (BCMA) half-life extended (HLE) BiTE (bispecific T-cell engager) molecule, in relapsed/refractory (RR) multiple myeloma (MM). Program and abstracts of the 2020 ASH Annual Meeting and Exposition; December 5-8, 2020. Abstract 181.
  66. ClinicalTrials.gov. A phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 701 monotherapy, or in combination with pomalidomide, with and without dexamethasone in subjects with relapsed or refractory multiple myeloma (ParadigMM-1B). Available at: https://clinicaltrials.gov/ct2/show/NCT03287908. Accessed March 5, 2021.
  67. Garfall AL, Usmani SZ, Mateos M, et al. Updated phase 1 results of teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in relapsed and/or refractory multiple myeloma (RRMM). Program and abstracts of the 2020 ASH Annual Meeting and Exposition; December 5-8, 2020. Abstract 180.
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  72. ClinicalTrials.gov. A phase 1, open-label study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of MEDI2228 in subjects with relapsed/refractory multiple myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT03489525. Accessed March 5, 2021.
  73. Cohen AD, Harrison SJ, Krishnan A, et al. Initial clinical activity and safety of BFCR4350A, a FcRH5/CD3 T-cell-engaging bispecific antibody, in relapsed/refractory multiple myeloma. Program and abstracts of the 2020 ASH Annual Meeting; December 5-8, 2020. Abstract 292.
  74. ClinicalTrials.gov. An open-label, multicenter, phase I trial evaluating the safety and pharmacokinetics of escalating doses of BFCR4350A in patients with relapsed or refractory multiple myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT03275103. Accessed March 5, 2021.
  75. Smith EL, Harrington K, Staehr M, et al. GPRC5D is a target for the immunotherapy of multiple myeloma with rationally designed CAR T cells. Sci Transl Med. 2019;11:(485):eaau7746.
  76. Chari A, Berdeja JG, Oriol A, et al. A phase 1, first-in-human study of talquetamab, a G protein-coupled receptor family C group 5 member D (GPRC5D) x CD3 bispecific antibody, in patients with relapsed and/or refractory multiple myeloma (RRMM). Program and abstracts of the 2020 ASH Annual Meeting; December 5-8, 2020. Abstract 290.
  77. ClinicalTrials.gov. A phase 1, first-in-human, open-label, dose escalation study of talquetamab, a humanized GPRC5D x CD3 bispecific antibody, in subjects with relapsed or refractory multiple myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT03399799. Accessed March 5, 2021.

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