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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.
FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma The confirmatory requirement was still open 0.1 years later, when the FDA's table was read.
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)
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)
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))
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))
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)
Observation with periodic labs; no treatment outside trials. (NCCN Observation)
A milestone in how this cancer is treated.
A milestone in how this cancer is treated.
Relapsed or refractory multiple myeloma after three or more lines including a proteasome inhibitor and an immunomodulatory agent
Subcutaneous daratumumab delayed progression to active myeloma or death compared with active monitoring in high-risk smouldering myeloma; approved in the United States in 2025.
MRD-neg 60.
PFS 36.
PFS HR 0.
ORR about 96% in infused patients (JAMA Oncol 2024).
PFS HR 0.
ORR 70%, ≥CR 45%.
A milestone in how this cancer is treated.
Relapsed or refractory multiple myeloma after three or more lines including a proteasome inhibitor and an immunomodulatory agent
With filgrastim, to mobilise haematopoietic stem cells for collection and autologous transplantation in multiple myeloma
PFS HR 0.
Overall response rate 75%, (stringent) complete response 50% and very good partial response 25% in the first 20 patients; grade 1 to 2 cytokine release syndrome in 90%, no grade 3 to 4 cytokine release syndrome or neurotoxicity; median progression-free survival 160 days.
PFS 13.
ORR 61%.
PFS HR 0.
A milestone in how this cancer is treated.
Early autologous transplant added to RVd and lenalidomide maintenance prolonged progression-free survival; overall survival did not differ at the primary analysis.
ORR 63%, ≥CR 39%.
ORR ~73%.
A milestone in how this cancer is treated.
A milestone in how this cancer is treated.
ORR 98%; ~33% progression-free at 5 years without maintenance.
A milestone in how this cancer is treated.
A milestone in how this cancer is treated.
Multiple myeloma in combination with other antimyeloma products (Hemady)
Relapsed/refractory multiple myeloma (≥4 lines) with dexamethasone
Daratumumab added to VTd increased stringent complete responses and lengthened progression-free survival; approved for transplant-eligible myeloma in 2019 (EU) and 2020 (US).
Daratumumab, lenalidomide and dexamethasone improved progression-free and later overall survival over lenalidomide and dexamethasone in transplant-ineligible newly diagnosed myeloma; approved in June 2019.
A milestone in how this cancer is treated.
Multiple myeloma after 1-3 prior therapies, with lenalidomide-dexamethasone
Multiple myeloma after ≥1 prior therapy, with lenalidomide and dexamethasone
Relapsed/refractory multiple myeloma
Multiple myeloma after ≥2 regimens including bortezomib and an IMiD
A milestone in how this cancer is treated.
A milestone in how this cancer is treated.
Giant cell tumour of bone; hypercalcaemia of malignancy (2014); multiple myeloma (2018)
Relapsed/refractory multiple myeloma
Multiple myeloma after ≥2 therapies including lenalidomide and a proteasome inhibitor
Replacement therapy in hypogammaglobulinaemia with recurrent bacterial infections in CLL (after failed antibiotic prophylaxis) and plateau-phase multiple myeloma (after failed pneumococcal immunisation); primary immunodeficiency
Newly diagnosed multiple myeloma with dexamethasone
A milestone in how this cancer is treated.