Myeloom geassocieerde studies
Planned studies
| Naam | EMN39 |
| Titel | A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant Conditions |
| Fase | Fase 3 |
| Therapie | Linvoseltamab vs SOC |
| Doelstellingen | Efficacy |
| Populatie | Transplant ineligible NDMM |
| Eligibility | Eligibility criteria in protocol |
| Status | Not yet open |
| Informatie | clinicaltrials.gov/study/ NCT06932562 |
| Deelnemers | EMC, Rotterdam |
| Naam | QUINTESSENTIAL-2 |
| Titel | A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma |
| Fase | Fase 3 |
| Therapie | BMS-986393 Versus Standard Regimens |
| Doelstellingen | Efficacy (PFS) |
| Populatie | RRMM: Prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received < 2 cycles are still eligible) |
| Eligibility | Eligibility criteria in protocol |
| Status | Not yet open |
| Informatie | clinicaltrials.gov/study/NCT06615479 |
| Deelnemers | UMCG, Groningen; UMCU, Utrecht; UMCN, Nijmegen; MUMC, Maastricht, UAMC, Amsterdam |
Open studies
| Naam | NCT05652335 |
| Titel | Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated AL Amyloidosis |
| Fase | Fase 1 |
| Therapie | JNJ-79635322, a Trispecific Antibody |
| Doelstellingen | Safety and RP2D, part 1; dose escalation, part 2 dose expansion |
| Populatie | RRMM and previously treated AL amyloidosis , as described in the protocol |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Informatie | clinicaltrials.gov/study/NCT05652335 |
| Deelnemers | UMCU, Utrecht; UMCG, Groningen; AUMC, Amsterdam |
| Naam | SUCCESSOR-2 |
| Titel | A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma |
| Fase | Fase 3 |
| Therapie | MeziKD vs Kd |
| Doelstellingen | Efficacy (PFS) |
| Populatie | Prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received < 2 cycles are still eligible) |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Informatie | clinicaltrials.gov/study/ NCT05552976 |
| Deelnemers | MST, Twente; Amphia ZH, Breda |
| Naam | NCT05201781 |
| Titel | A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel |
| Fase | Fase 4, Data collection |
| Doelstellingen | Collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel. |
| Populatie | Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Informatie | clinicaltrials.gov/study/NCT05201781 |
| Deelnemers | UAMC, Amsterdam; UMCG, Groningen |
| Naam | MagnetisMM-32 |
| Titel | A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide |
| Fase | Fase 3 |
| Therapie | Elranatamab vs SOC (Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)) |
| Doelstellingen | Efficacy (oa PFS) |
| Populatie | 1 to 4 PL, including anti-CD38 antibody and prior lenalidomide. |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Informatie | clinicaltrials.gov/study/NCT06152575 |
| Deelnemers | MUMC, Maasstricht; ASZ, Dordrecht; EMC, Rotterdam |
| Naam | ITUMM |
| Titel | Telemonitoring Among Patients With Multiple Myeloma |
| Fase | Fase 3 |
| Therapie | Telemonitoring vs SOC monitoring |
| Doelstellingen |
Impact on Correct Drug Use, Complications and Quality of Life |
| Populatie | Multiple Myeloma |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Informatie | clinicaltrials.gov/study/NCT05964270 |
| Deelnemers | Zwolle, Overijssel, Netherlands |
| Naam | iMMagine-3 |
| Titel | A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (iMMagine-3) |
| Fase | Fase 3 |
| Therapie | Anitocabtagene Autoleucel vs SoC |
| Doelstellingen | Efficacy (PFS) |
| Populatie | Relapsed/ Refractory Multiple Myeloma |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Informatie | clinicaltrials.gov/study/NCT06413498 |
| Deelnemers | UMCG, Groningen |
| Naam | EMN40 |
| Titel | A Phase 2 Trial of Teclistamab in participants with previously treated Immunoglobulin Light-Chain (AL) Amyloidosis |
| Fase | Fase 2 |
| Therapie | Teclistamab monotherapy, duration 6 months |
| Doelstellingen | Hematological CR rate after 3 cycles |
| Populatie | Relapsed patients with AL amyloidosis |
| Eligibility | Previously treated with an alkylating agent and/or a proteasome inhibitor and dexamethasone and/or daratumumab and/or IMID. Measurable hematological disease (dFLC > 20), eGFR > 20 ml/min |
| Status | Open 15 June 2025 |
| Informatie | EMN40 - European Myeloma Network |
| Deelnemers | UMC Utrecht |
| Naam | EMN28/Cartitude-6/EM-agine |
| Titel | A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible |
| Fase | Fase 3 |
| Therapie | Dara-VRD/HDM/ASCT vs DaraVRD/CAR-T |
| Doelstellingen | Efficacy (PFS) en safety |
| Populatie | NDMM TE patients |
| Eligibility | NDMM transplant eligible |
| Status | Open |
| Informatie | EMN28 - European Myeloma Network |
| Deelnemers | EMC, Amsterdam UMC, UMCU, UMCG, Radboud UMC |
| Naam | EMN33/ TAURUS |
| Titel | Phase 2 Study Applying Innovative Minimal Residual Disease (MRD) Techniques for Participants with Previously Untreated Multiple Myeloma Treated with Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) Prior To and After High-dose Therapy Followed by Autologous Stem Cell Transplantation (ASCT) - TAURUS |
| Fase | Fase 2 |
| Therapie | Dara-VRD, HDM/ASCT. Gebuik makend van bloodbased MRD |
| Doelstellingen | Efficacy (PFS) en safety |
| Populatie | NDMM TE patients |
| Eligibility | NDMM transplant eligible |
| Status | Open |
| Informatie | EMN 33 - European Myeloma Network |
| Deelnemers | Many hospitals in the Netherlands, inform at a centre near you |
| Naam | EMN30/ MAJESTEC-4 |
| Titel | Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation – The Majestec-4 study |
| Fase | Fase 3, onderhoud |
| Therapie | Teclistamab/ Lenalidomide vs. Teclistamab vs. Lenalidomide |
| Doelstellingen | Efficacy (PFS) en safety |
| Populatie | NDMM TE patients |
| Eligibility | NDMM transplant eligible |
| Status | Open |
| Informatie | EMN30 - European Myeloma Network |
| Deelnemers | EMC, Amsterdam UMC, UMCG, ASZ, and other centres, inform at a centre near you |
| Naam | MAGNETISMM-6 |
| Titel | Randomized Phase 3 Study To Evaluate The Efficacy And Safety Of Elranatamab (Pf-06863135) + Daratumumab + Lenalidomide Versus Daratumumab + Lenalidomide + Dexamethasone In Transplant-ineligible Participants With Newly-diagnosed Multiple Myeloma |
| Fase | Fase 3 |
| Therapie | Elranatamab + daratumumab + lenalidomide (EDR) versus Daratumumab + lenalidomide + dexamethasone (DRd) |
| Doelstellingen | Efficacy (PFS) en safety |
| Populatie | NDMM TIE patients |
| Eligibility | NDMM transplant ineligible |
| Status | Open |
| Informatie | https://clinicaltrials.gov/study/NCT05623020 |
| Deelnemers | VieCuri, ASZ |
| Naam | Excaliber-maintenance |
| Titel | A Randomized, 2-arm, Phase 3 Study Of Elranatamab (Pf-06863135) Versus Lenalidomide In Patients With Newly Diagnosed Multiple Myeloma After Undergoing Autologous Stem-cell Transplantation |
| Fase | Fase 3, onderhoud |
| Therapie | Iber vs len onderhoud na autoPSCT |
| Doelstellingen | Efficacy (PFS) en safety |
| Populatie | NDMM TE patients, onderhoud |
| Eligibility | NDMM transplant eligible |
| Status | Open |
| Informatie | https://clinicaltrials.gov/study/NCT05317416 |
| Deelnemers | ASZ Dordrecht |
| Naam | MAJESTEC-7 |
| Titel | A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy |
| Fase | Fase 3 |
| Therapie | Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) |
| Doelstellingen | Efficacy (PFS) en safety |
| Populatie | NDMM TE patients |
| Eligibility | NDMM transplant eligible |
| Status | Open |
| Informatie | https://clinicaltrials.gov/study/NCT05552222 |
| Deelnemers | Amsterdam UMC; Antonius; Reinier de Graaf ZH Delft;
Gelre ZH, Apeldoorn; St Antonius ZH, Nieuwegein; Zuiderland Medisch centrum, Sittard-Geleen |
| Naam | MagnestisMM-7 |
| Titel | A Randomized, 2-Arm, Phase 3 Study of Elranatamab (PF-06863135) Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease-Positive After Undergoing Autologous Stem-Cell Transplantation |
| Fase | Fase 3 |
| Therapie | Elranatamab Versus Lenalidomide maintenance |
| Doelstellingen | Safety and Efficacy (part 1, safety lead-in, part 2 randomized) |
| Populatie |
Patients With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease-Positive After Undergoing Autologous Stem-Cell Transplantation. |
| Eligibility | Eligibility criteria in protocol |
| Status | Open in HAGAZH |
| Informatie | https://clinicaltrials.gov/ct2/show/NCT05317416 |
| Deelnemers |
Isala ZH, Zwolle; MUMC, Maastricht |
| Naam | MagnestisMM-5 |
| Titel |
A Phase 3 Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma |
| Fase | Phase 3 |
| Therapie | Elranatamab Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone |
| Doelstellingen | Safety and Efficacy (part 1, safety lead-in, part 2 randomized) |
| Populatie |
Only open for part 2 |
| Eligibility | Eligibility criteria in protocol |
| Status | Not open yet |
| Referentie | https://clinicaltrials.gov/ct2/show/NCT05020236 |
| Deelnemers |
MUMC / ErasmusMC |
| Naam | MonumenTAL-6 |
| Titel | A phase 3 randomized study comparing talquetamab in combination with pomalidomide (Tal-P), talquetamab in combination with teclistamab (Tal-Tec) and investigator’s choice of either elotuzumab, pomalidomide and dexamethasone (EPd) or pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory myeloma who have received 1 to4 prior lines of therapy including an anti-CD38 antibody and lenalidomide |
| Fase | Fase 3 |
| Therapie | Talquetamab+pomalidomide versus Talquetamab+teclistamab versus elotuzumab+pomalidomide (EPd) of pomalidomide+bortezomib (PVd) |
| Doelstellingen | Efficacy (PFS) en safety |
| Populatie | RRMM |
| Eligibility | RRMM, 1-4 eerdere lijnen (behandeld met lenalidomide en antiCD38 antistof) |
| Status | Open |
| Referentie | https://clinicaltrials.gov/study/NCT06208150 |
| Deelnemers |
Flevoziekenhuis, Almere; HagaZH, Den Haag; Catherina ZH, Eindhoven; AntoniusZH, Nieuwegein; IsalaZH, Zwolle |
Closed studies
EMN29
Majestec-3
Majestec-9
EXCALIBER
Trimm-2 studie
Majestec-1
Monumental-1
Monumental-2
Monumental-3
Celgene CC-220-MM-001
ICON
LAVA
Gen3014-01
CA058-002
EMN34/ ERASMM
79635322MMY1001
EMN22
LYNX