What changed: Multiple myeloma
Every dated change on the records linked to Multiple myeloma, newest first: approvals and regulatory steps on its medicines, trials that reported, guideline versions, milestones, and when this page itself was checked. Dates come from the records; none is inferred. Orientation, not medical advice.
September 2026 · 1
August 2026 · 3
- 2026-08-13RegulatoryDaratumumabDaratumumab: approval (US)
FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
- 2026-08-13RegulatoryDexamethasoneDexamethasone: approval (US)
FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
- 2026-08-13RegulatoryIberdomideIberdomide: approval (US)
FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
July 2026 · 2
March 2026 · 1
Q1 2026 · 1
February 2026 · 1
2026 · 11
- 2026ApprovalDaratumumabDaratumumab approved in US
With teclistamab after ≥1 line (MajesTEC-3); high-risk smouldering myeloma (AQUILA)
- 2026ApprovalIberdomideIberdomide approved in US
Multiple myeloma after at least one prior line including a proteasome inhibitor and an immunomodulatory agent, with subcutaneous daratumumab and dexamethasone (Zenbexus, label effective 13 August 2026)
- 2026ApprovalIsatuximabIsatuximab approved in US
Subcutaneous formulation (Sarclisa Escena)
- 2026ApprovalTeclistamabTeclistamab approved in US
Relapsed/refractory myeloma after ≥1 prior therapy
- 2026GuidelineMultiple myelomaGuideline NCCN 2026 / EHA-ESMO 2021 update: Newly diagnosed, transplant-eligible
Dara-VRd (or Isa-VRd) induction × 4-6 → stem-cell collection → high-dose melphalan + autologous transplant → Dara-VRd consolidation → lenalidomide (± daratumumab) maintenance; MRD-guided de-escalation emerging (PERSEUS design). Tandem transplant or extended therapy for high risk. (NCCN Category 1 (Dara-VRd), ESMO-MCBS A)
- 2026GuidelineMultiple myelomaGuideline NCCN 2026: First relapse (1-3 prior lines)
Cilta-cel if lenalidomide-refractory (CARTITUDE-4); teclistamab + daratumumab (MajesTEC-3, 2026); ide-cel after ≥2 lines; belantamab-Vd or -Pd (DREAMM-7/8); CD38-based triplets (Dara-Kd, Isa-Kd, Dara-Pd) by prior exposure; carfilzomib or pomalidomide combinations. (NCCN Category 1 (cilta-cel ≥1 line; tec-dara ≥1 line))
- 2026GuidelineMultiple myelomaGuideline NCCN 2026: High-risk smouldering myeloma
Consider daratumumab monotherapy (AQUILA) or lenalidomide (E3A06), or trial enrolment; shared decision given indolent course in many. (NCCN Category 2A (daratumumab or lenalidomide for high-risk SMM))
- 2026GuidelineMultiple myelomaGuideline NCCN 2026: Newly diagnosed, transplant-ineligible
Dara-VRd (CEPHEUS) or Isa-VRd (IMROZ) with bortezomib de-escalation after induction; Dara-Rd (MAIA) for frailer patients; continuous therapy with dose adjustment for frailty. (NCCN Category 1)
- 2026GuidelineMultiple myelomaGuideline NCCN Multiple Myeloma 2026: MGUS / low-risk smouldering
Observation with periodic labs; no treatment outside trials. (NCCN Observation)
- 2026MilestoneMajesTEC-3Teclistamab + daratumumab approved after ≥1 line (MajesTEC-3); isatuximab subcutaneous; anito-cel BLA accepted (PDUFA December)
A milestone in how this cancer is treated.
- 2026MilestoneMultiple myelomaTeclistamab after ≥1 line; isatuximab SC
A milestone in how this cancer is treated.
October 2025 · 1
July 2025 · 2
June 2025 · 1
2025 · 7
- 2025ApprovalBelantamab mafodotinBelantamab mafodotin approved in EU
R/R myeloma with BorDex or PomDex; 23 Jul 2025
- 2025ApprovalBelantamab mafodotinBelantamab mafodotin approved in US
Relapsed/refractory myeloma after ≥1 prior line, in combination
- 2025ApprovalLinvoseltamabLinvoseltamab approved in EU
R/R myeloma ≥3 lines; 23 Apr 2025 (conditional)
- 2025ApprovalLinvoseltamabLinvoseltamab approved in US
Relapsed/refractory myeloma after ≥4 lines (accelerated)
- 2025Trial resultiMMagine-1iMMagine-1 reported
ORR 97%.
- 2025Trial resultMajesTEC-3MajesTEC-3 reported
36-month PFS 83.
- 2025MilestoneLinvoseltamabLinvoseltamab approved; belantamab re-approved; IMROZ/CEPHEUS labels; iMMagine-1 reports 97% ORR
A milestone in how this cancer is treated.
September 2024 · 1
July 2024 · 1
April 2024 · 1
February 2024 · 1
January 2024 · 1
2024 · 12
- 2024ApprovalCiltacabtagene autoleucelCiltacabtagene autoleucel approved in US
Relapsed myeloma after ≥1 line, lenalidomide-refractory
- 2024ApprovalDaratumumabDaratumumab approved in US
Newly diagnosed transplant-eligible with VRd (PERSEUS)
- 2024ApprovalIdecabtagene vicleucelIdecabtagene vicleucel approved in US
After ≥2 lines including IMiD, PI, and anti-CD38
- 2024ApprovalIsatuximabIsatuximab approved in US
Newly diagnosed transplant-ineligible with VRd (IMROZ)
- 2024ApprovalZevorcabtagene autoleucelZevorcabtagene autoleucel approved in China
Relapsed or refractory multiple myeloma after three or more lines including a proteasome inhibitor and an immunomodulatory agent
- 2024Trial resultCEPHEUSCEPHEUS reported
MRD-neg 60.
- 2024Trial resultDREAMM-7DREAMM-7 reported
PFS 36.
- 2024Trial resultDREAMM-8DREAMM-8 reported
PFS HR 0.
- 2024Trial resultFUMANBA-1FUMANBA-1 reported
ORR about 96% in infused patients (JAMA Oncol 2024).
- 2024Trial resultIMROZIMROZ reported
PFS HR 0.
- 2024Trial resultLINKER-MM1LINKER-MM1 reported
ORR 70%, ≥CR 45%.
- 2024MilestonePERSEUSPERSEUS quadruplet approved; FDA accepts MRD as an endpoint; DREAMM-7/8 positive; cilta-cel and ide-cel approved after 1-2 lines
A milestone in how this cancer is treated.
2023 · 9
- 2023ApprovalElranatamabElranatamab approved in US
Relapsed/refractory myeloma after ≥4 lines (accelerated)
- 2023ApprovalEquecabtagene autoleucelEquecabtagene autoleucel approved in China
Relapsed or refractory multiple myeloma after three or more lines including a proteasome inhibitor and an immunomodulatory agent
- 2023ApprovalMotixafortideMotixafortide approved in US
With filgrastim, to mobilise haematopoietic stem cells for collection and autologous transplantation in multiple myeloma
- 2023ApprovalTalquetamabTalquetamab approved in US
Relapsed/refractory myeloma after ≥4 lines (accelerated)
- 2023Trial resultCARTITUDE-4CARTITUDE-4 reported
PFS HR 0.
- 2023Trial resultKarMMa-3KarMMa-3 reported
PFS 13.
- 2023Trial resultMagnetisMM-3MagnetisMM-3 reported
ORR 61%.
- 2023Trial resultPERSEUSPERSEUS reported
PFS HR 0.
- 2023MilestoneCARTITUDE-4CARTITUDE-4 and KarMMa-3 move CAR-T earlier; elranatamab and talquetamab approved
A milestone in how this cancer is treated.
November 2022 · 1
October 2022 · 1
August 2022 · 1
February 2022 · 1
2022 · 7
- 2022ApprovalCiltacabtagene autoleucelCiltacabtagene autoleucel approved in US
Relapsed/refractory myeloma ≥4 lines
- 2022ApprovalTeclistamabTeclistamab approved in EU
R/R myeloma ≥3 lines (conditional, Aug 2022)
- 2022ApprovalTeclistamabTeclistamab approved in US
Relapsed/refractory myeloma after ≥4 lines
- 2022Trial resultMajesTEC-1MajesTEC-1 reported
ORR 63%, ≥CR 39%.
- 2022Trial resultMonumenTAL-1MonumenTAL-1 reported
ORR ~73%.
- 2022MilestoneTeclistamabTeclistamab: first myeloma bispecific
A milestone in how this cancer is treated.
- 2022MilestoneTeclistamabTeclistamab: first myeloma bispecific; cilta-cel approved
A milestone in how this cancer is treated.
June 2021 · 1
2021 · 4
- 2021ApprovalIdecabtagene vicleucelIdecabtagene vicleucel approved in US
Relapsed/refractory myeloma after ≥4 lines
- 2021Trial resultCARTITUDE-1CARTITUDE-1 reported
ORR 98%; ~33% progression-free at 5 years without maintenance.
- 2021MilestoneMultiple myelomaIde-cel: first myeloma CAR-T
A milestone in how this cancer is treated.
- 2021MilestoneIdecabtagene vicleucelIde-cel: first myeloma CAR-T; CARTITUDE-1 shows 98% response
A milestone in how this cancer is treated.
August 2020 · 1
May 2020 · 1
2020 · 3
- 2020ApprovalBelantamab mafodotinBelantamab mafodotin approved in US
Relapsed myeloma ≥4 lines (accelerated; withdrawn 2022)
- 2020ApprovalIsatuximabIsatuximab approved in US
Relapsed myeloma with pomalidomide-dexamethasone; 2021 with carfilzomib-dexamethasone
- 2020MilestoneBelantamab mafodotinBelantamab mafodotin: first BCMA ADC (accelerated; withdrawn 2022)
A milestone in how this cancer is treated.
December 2019 · 1
2019 · 4
- 2019ApprovalDaratumumabDaratumumab approved in US
Newly diagnosed, transplant-ineligible with Rd (MAIA) and VMP
- 2019ApprovalDexamethasoneDexamethasone approved in US
Multiple myeloma in combination with other antimyeloma products (Hemady)
- 2019ApprovalSelinexorSelinexor approved in US
Relapsed/refractory multiple myeloma (≥4 lines) with dexamethasone
- 2019MilestoneDaratumumabMAIA: Dara-Rd improves survival in transplant-ineligible disease
A milestone in how this cancer is treated.
2018 · 2
2017 · 1
2016 · 2
November 2015 · 1
2015 · 8
- 2015ApprovalCarfilzomibCarfilzomib approved in US
With lenalidomide-dexamethasone; with dexamethasone (ENDEAVOR)
- 2015ApprovalDaratumumabDaratumumab approved in US
Relapsed myeloma after ≥3 lines
- 2015ApprovalElotuzumabElotuzumab approved in US
Multiple myeloma after 1-3 prior therapies, with lenalidomide-dexamethasone
- 2015ApprovalIxazomibIxazomib approved in US
Multiple myeloma after ≥1 prior therapy, with lenalidomide and dexamethasone
- 2015ApprovalPanobinostatPanobinostat approved in EU
Relapsed/refractory multiple myeloma
- 2015ApprovalPanobinostatPanobinostat approved in US
Multiple myeloma after ≥2 regimens including bortezomib and an IMiD
- 2015MilestoneMultiple myelomaDaratumumab approved
A milestone in how this cancer is treated.
- 2015MilestoneDaratumumabDaratumumab: first CD38 antibody; R-ISS published
A milestone in how this cancer is treated.
2013 · 3
- 2013ApprovalDenosumabDenosumab approved in US
Giant cell tumour of bone; hypercalcaemia of malignancy (2014); multiple myeloma (2018)
- 2013ApprovalPomalidomidePomalidomide approved in EU
Relapsed/refractory multiple myeloma
- 2013ApprovalPomalidomidePomalidomide approved in US
Multiple myeloma after ≥2 therapies including lenalidomide and a proteasome inhibitor
2012 · 2
2011 · 1
2009 · 1
2008 · 3
- 2008ApprovalBortezomibBortezomib approved in US
Newly diagnosed myeloma
- 2008ApprovalPlerixaforPlerixafor approved in US
Stem cell mobilisation with filgrastim for autologous transplantation in NHL and multiple myeloma
- 2008ApprovalThalidomideThalidomide approved in EU
Untreated multiple myeloma ≥65 or transplant-ineligible, with melphalan-prednisone