Myeloom geassocieerde studies
| Naam | Cartitude-5 |
| Titel | A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy (CARTITUDE-5) |
| Fase | Fase III |
| Therapie | VRd, Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T ell (CAR-T) Therapy Directed Against BCMA Versus VRd Followed by Rd |
| Doelstellingen | Efficacy and safety |
| Populatie | NDMM transplant ineligible patients |
| Eligibility |
Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria |
| Status | Open |
| Informatie | https://clinicaltrials.gov/ct2/show/NCT04923893 |
| Deelnemers | AmsterdamAMC / EMC / UMCG / Radboudumc |
| 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 | AmsterdamAMC HagaZiekenhuis |
| 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 | Open |
| Informatie | https://clinicaltrials.gov/ct2/show/NCT04108195 |
| Deelnemers | Amsterdam UMC - AMC |
| 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 - AMC |
| 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 | MUMC |
| 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 | 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 | Phase 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 | Not open yet |
| Referentie | https://clinicaltrials.gov/ct2/show/NCT05317416 |
| Deelnemers |
MUMC |
| 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, AMC, 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 | Open |
| 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 |
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 |