Myeloom geassocieerde studies
| 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, Amsterdam UMC |
| 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 |
| 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 | MUMC/HAGAZH |
| Naam | EMN 29 |
| Titel | Phase 3 randomized, open-label trial of selinexor, pomalidomide, and dexamethasone (SPd) versus elotuzumab, pomalidomide, and dexamethasone (EloPd) in patients with relapsed or refractory multiple myeloma |
| Fase | Fase 3 |
| Therapie | SPd versus EPd |
| Doelstellingen | Efficacy (PFS) en safety |
| Populatie | RRMM patients |
| Eligibility |
Relapsed/refractory MM, received at least 1 and no more than 4 lines of prior anti-MM regimens. |
| Status | Open |
| Informatie | https://clinicaltrials.gov/ct2/show/NCT05028348 |
| Deelnemers | EMC, Amphia ziekenhuis |
| Naam | Majestec-3 |
| Titel | A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma |
| Fase | Fase 3 |
| Therapie | Tec-Dara vs DPD or DVd |
| Doelstellingen | Efficacy (PFS) |
| Populatie | RRMM patients |
| Eligibility | Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. |
| Status | Dicht voor inclusie |
| Informatie | https://clinicaltrials.gov/ct2/show/NCT05083169 |
| Deelnemers | RadboudUMC, UMCG |
| Naam | Majestec-9 |
| Titel | A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma |
| Fase | Fase 3 |
| Therapie | TEC vs Kd or PVD |
| Doelstellingen | Efficacy (PFS) |
| Populatie | RRMM patients |
| Eligibility | Relapsed / refractory MM as defined by Durie et al Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti-CD38 monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line |
| Status | Open |
| Informatie | https://clinicaltrials.gov/study/NCT05572515 |
| Deelnemers | UMCU, UMCG, Amsterdam UMC |
| Naam | Monumental-3 |
| Titel | A Phase 3 Randomized Study Comparing Talquetamab in Combination with Daratumumab and Pomalidomide or Talquetamab in combination with Daratumumab versus Daratumumab, Pomalidomide and Dexamethasone (DPd), in Subjects with Lenalidomide-Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy |
| Fase | Fase 3 |
| Therapie | TalDPvs TalD vs DPd |
| Doelstellingen | Safety |
| Populatie | RRMM ≥2 PL. Or 1 PL and len refractory. Not anti-CD38 refractory |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Informatie | https://clinicaltrials.gov/study/NCT03399799 |
| Deelnemers | MUMC, EMC |
| Naam | EXCALIBER |
| Titel | Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (EXCALIBER-RRMM) |
| Fase | Fase 3 |
| Therapie | iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) |
| Doelstellingen | Efficacy and safety |
| Populatie | RRMM patients |
| Eligibility | Relapsed / refractory MM as defined by Durie et al 1 to 2 prior lines of anti-myeloma therapy Eligibility criteria in protocol |
| Status | Open |
| Informatie | https://clinicaltrials.gov/ct2/show/NCT04975997 |
| Deelnemers | Amsterdam UMC |
| Naam | Trimm-2 studie |
| Titel | A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma |
| Fase | Fase Ib |
| Therapie | 1) daratumumab plus teclistamab or 2) daratumumab plus talquetamab or 3) daratumumab plus talquetamab plus pomalidomide or 4) daratumumab plus teclistamab plus pomalidomide. |
| Doelstellingen | Safety and tolerability |
| Populatie | RRMM patients |
| Eligibility | Relapsed / refractory MM as defined by Durie et al > 3PL, of > 2 als double refr to PI/IMID Eligibility criteria in protocol |
| Status | Dicht voor inclusie |
| Informatie | https://clinicaltrials.gov/ct2/show/NCT04108195 |
| Deelnemers | AmsterdamAMC |
| Naam | Majestec-1 |
| Titel | A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma |
| Fase | Phase 1/2 |
| Therapie | Teclistamab |
| Doelstellingen | Safety and tolerability |
| Populatie | RRMM patients |
| Eligibility | Relapsed / refractory MM as defined by Durie et al Cohort A: received at least 3 prior MM treatment lines of therapy; Cohort C: received >= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CAR-T cells or an antibody drug conjugate (ADC) Eligibility criteria in protocol |
| Status | Open |
| Referentie | https://clinicaltrials.gov/ct2/show/NCT04557098 |
| Deelnemers |
Amsterdam UMC |
| Naam | Monumental-1, Anti GPRC5D duobody studie |
| Titel | A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized DuoBody® Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma |
| Fase | Phase 1 |
| Therapie | JNJ-64407564 |
| Doelstellingen | Safety |
| Populatie | Subjects with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Referentie | https://clinicaltrials.gov/ct2/show/NCT03399799 |
| Deelnemers | Amsterdam UMC, prof N. van de Donk. UMCU, prof. M.C. Minnema |
| Naam | Monumental-2, Anti GPRC5D duobody studie |
| Titel | A Phase 1/2, 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 |
| Fase | Phase 1/2 |
| Therapie | Talquetamab |
| Doelstellingen | Efficacy on the RP2D |
| Populatie | 3 cohorts: A) ≥3 prior lines of therapy and have not been exposed to T cell redirection therapies. B) ≥3 prior lines of therapy and have been exposed to T cell redirection therapies. C) ≥3 prior lines of therapy and have not been exposed to T cell redirection therapies. Talquetamab biweekly |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Referentie | https://clinicaltrials.gov/ct2/show/NCT04634552 |
| Deelnemers | UMCU, MUMC, UMCG |
| Naam | Monumental-3 |
| Titel | A Phase 3 Randomized Study Comparing Talquetamab in Combination with Daratumumab and Pomalidomide or Talquetamab in combination with Daratumumab versus Daratumumab, Pomalidomide and Dexamethasone (DPd), in Subjects with Lenalidomide-Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy |
| Fase | Phase 3 |
| Therapie | TalDPvs TalD vs DPd |
| Doelstellingen | Safety |
| Populatie | RRMM ≥2 PL. Or 1 PL and len refractory. Not anti-CD38 refractory |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Referentie | n.a. |
| Deelnemers |
MUMC (vertraging), EMC (vertaging) |
| 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 | Celgene CC-220-MM-001 |
| Titel | A Phase 1b/2a Multicenter, Open-label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination with other Treatments in Subjects with Multiple Myeloma |
| Fase | Phase I/2a |
| Therapie | CC-220 (Iberdomide) |
| Doelstellingen | Safety/efficacy |
| Populatie | Subjects with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Referentie | https://clinicaltrials.gov/ct2/show/NCT02773030 |
| Deelnemers |
Amsterdam UMC: Prof. dr. N. v.d. Donk |
| Naam | ICON |
| Titel | A phase 2 study of CC220 (iberdomide) combined with low-dose cyclophosphamide and dexamethasone in relapsed/refractory multiple myeloma (IberCd): ICON STUDY |
| Fase | Phase 2 |
| Therapie | Iberdomide combined with low-dose cyclophosphamide and dexamethasone |
| Doelstellingen | Efficacy, safety |
| Populatie | Relapsed/refractory multiple myeloma, 2-4 prior lines |
| Status | Open |
| Referentie | https://clinicaltrials.gov/ct2/show/NCT04392037 |
| Deelnemers | ASZ, van Weel Bethesda, Ikazia, MaasstadZH, Amsterdam UMC, Radboudumc en Rijnstate |
| Naam | LAVA |
| Titel |
A phase 1 and 2a open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and antitumor activity of LAVA-051 in patients with relapsed or refractory CD1d-positive chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemia |
| Fase | Phase 1 |
| Therapie | LAVA-051, Gammabody: activates Vγ9Vδ2 T cells and type 1 NKT cells targeting CD1d expressing MM (CLL/AML) |
| Doelstellingen | Safety |
| Populatie | Subjects with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies |
| Status | Closed |
| Referentie |
https://www.hematologie-wijzer.nl/home/studieprotocollen/cll |
| Deelnemers | Amsterdam UMC - AMC (A. Kater) Amsterdam UMC - VUmc (N. van de Donk) ErasmusMC (A. Broijl) |
| Naam | Gen3014-01 |
| Titel | GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies |
| Fase | Phase 1/2 |
| Therapie | GEN3014 (HexaBody®-CD38) |
| Doelstellingen | Safety, dose escalation and expansion phase |
| Populatie | anti-CD38 mAb-treated RRMM Cohort: Subject has received at least 2 prior lines of therapy and must have discontinued daratumumab or isatuximab for at least 4 weeks prior to the first dose of GEN3014. |
| Status | Open |
| Referentie | https://clinicaltrials.gov/ct2/show/NCT04824794 |
| Deelnemenrs |
UMCU (dr. Minnema) |
| Naam | LYNX |
| Titel | A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab to Evaluate Daratumumab Retreatment |
| Fase | Phase2 |
| Therapie | Dara-Kd vs Kd |
| Doelstellingen | Efficacy, safety |
| Populatie | Relapsed/refractory multiple myeloma, Previously Treated With Daratumumab, 1-3 prior lines |
| Status | Open |
| Referentie | https://clinicaltrials.gov/ct2/show/NCT03871829 |
| Deelnemers | ASZ, van Weel Bethesda, Ikazia, MaasstadZH |
| Naam | CA058-002 |
| Titel | A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma |
| Fase | Fase 1b/2a |
| Therapie | Alnuctamab/ Mezigdomide |
| Doelstellingen | Safety and tolerability |
| Populatie | RRMM patients |
| Eligibility | Relapsed / refractory MM as defined by Durie et al Eligibility criteria in protocol |
| Status | Open |
| Referentie | https://clinicaltrials.gov/study/NCT06163898 |
| Deelnemers | UMCG/UMCU |
| Naam | EMN34/ ERASMM |
| Titel | Phase 2 study for the Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma |
| Fase | Fase 2 |
| Therapie | Elranatamab monotherapy |
| Doelstellingen | Safety and efficacy |
| Populatie | High-risk SMM patients, high-risk as defined by 20-2-20 criteria |
| Eligibility |
Eligibility criteria in protocol, high-risk based on 20-2-20 criteria. |
| Status | Open |
| Referentie | https://clinicaltrials.gov/study/NCT06183489 |
| Deelnemers | MUMC (dr van Elsen), Antonius ZH (dr Nijhof), ErasmusMC (dr. Broijl) |
| Naam | 79635322MMY1001 |
| Titel | A Phase 1 Study of JNJ-79635322 in Participants with Relapsed or Refractory Multiple Myeloma |
| Fase | Fase 1 |
| Therapie | JNJ-79635322 |
| Doelstellingen | Safety and tolerability |
| Populatie | RRMM patients |
| Eligibility | Have relapsed or refractory disease and have been treated with a proteasome inhibitor, IMiD agent, and an anti-CD38-based therapy for the treatment of MM |
| Status | Open |
| Referentie | https://clinicaltrials.gov/study/NCT05652335 |
| Deelnemers | Amsterdam UMC, UMCU |
AL amyloidosis
| Naam | EMN22 |
| Titel | Phase 2 study of Daratumumab monotherapy in previously untreated patients with 3B light chain (AL) amyloidosis |
| Fase | Phase 2 |
| Therapie | Daratumumab monotherapy |
| Doelstellingen | Overall survival (OS) rate at 6 months, ORR, VGPR and CR rate |
| Populatie | Previously untreated patients with 3B light chain (AL) amyloidosis |
| Eligibility |
Eligibility criteria in protocol |
| Status | Open |
| Referentie | |
| Deelnemers | UMC Utrecht, Prof Dr MC Minnema |