Myeloma Associated studies
| Short name | Cartitude-5 |
| Title | 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) |
| Phase | Phase III |
| Therapy | VRd, Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T ell (CAR-T) Therapy Directed Against BCMA Versus VRd Followed by Rd |
| Objectives | Efficacy and safety |
| Population | NDMM transplant ineligible patients |
| Eligibility |
Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria |
| Status | Open |
| Information | https://clinicaltrials.gov/ct2/show/NCT04923893 |
| Participants | AmsterdamAMC / EMC / UMCG / Radboudumc |
| Short name | EXCALIBER |
| Title | 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) |
| Phase | Phase 3 |
| Therapy | iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) |
| Objectives | Efficacy and safety |
| Population | 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 |
| Information | https://clinicaltrials.gov/ct2/show/NCT04975997 |
| Participants |
AmsterdamAMC |
| Short name | Trimm-2 study |
| Title | A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma |
| Phase | Phase Ib |
| Therapy | 1) daratumumab plus teclistamab or 2) daratumumab plus talquetamab or 3) daratumumab plus talquetamab plus pomalidomide or 4) daratumumab plus teclistamab plus pomalidomide. |
| Objectives | Safety and tolerability |
| Population | 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 |
| Information | https://clinicaltrials.gov/ct2/show/NCT04108195 |
| Participants | Amsterdam UMC - AMC |
| Short name | Majestec-1 |
| Title | 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 |
| Phase | Phase I/II |
| Therapy | Teclistamab |
| Objectives | Safety and tolerability |
| Population | 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 |
| Reference | https://clinicaltrials.gov/ct2/show/NCT04557098 |
| Participants |
Amsterdam UMC - AMC |
| Short name | Monumental-1, Anti GPRC5D duobody study |
| Title | 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 |
| Phase | Phase 1 |
| Therapy | JNJ-64407564 |
| Objectives | Safety |
| Population | Subjects with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Reference | https://clinicaltrials.gov/ct2/show/NCT03399799 |
| Participants |
Amsterdam UMC: Prof. dr. N. van de Donk |
| Short name | Monumental-2, Anti GPRC5D duobody study |
| Title | 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 |
| Phase | Phase 1/2 |
| Therapy | Talquetamab |
| Objectives | Efficacy on the RP2D |
| Population | 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 |
| Reference | https://clinicaltrials.gov/ct2/show/NCT04634552 |
| Participants | MUMC |
| Short name | Monumental-3 |
| Title | 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 |
| Phase | Phase 3 |
| Therapy | TalDPvs TalD vs DPd |
| Objectives | Safety |
| Population | RRMM ≥2 PL. Or 1 PL and len refractory. Not anti-CD38 refractory |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Reference | n.a. |
| Participants |
MUMC (delayed), EMC (delayed) |
| Short name | MagnestisMM-5 |
| Title |
A Phase 3 Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma |
| Phase | Phase 3 |
| Therapy | Elranatamab Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone |
| Objectives | Safety and Efficacy (part 1, safety lead-in, part 2 randomized) |
| Population |
Only open for part 2 |
| Eligibility | Eligibility criteria in protocol |
| Status | Not open yet |
| Reference | https://clinicaltrials.gov/ct2/show/NCT05020236 |
| Participants |
MUMC / ErasmusMC |
| Short name | MagnestisMM-7 |
| Title | 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 |
| Phase | Phase 3 |
| Therapy | Elranatamab Versus Lenalidomide maintenance |
| Objectives | Safety and Efficacy (part 1, safety lead-in, part 2 randomized) |
| Population |
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 |
| Reference | https://clinicaltrials.gov/ct2/show/NCT05317416 |
| Participants |
MUMC |
| Short name | Celgene CC-220-MM-001 |
| Title | 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 |
| Phase | Phase I/2a |
| Therapy | CC-220 (Iberdomide) |
| Objectives | Safety/efficacy |
| Population | Subjects with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies |
| Eligibility | Eligibility criteria in protocol |
| Status | Open |
| Reference | https://clinicaltrials.gov/ct2/show/NCT02773030 |
| Participants |
Amsterdam UMC: Prof. dr. N. v.d. Donk |
| Short name | ICON |
| Title | A phase 2 study of CC220 (iberdomide) combined with low-dose cyclophosphamide and dexamethasone in relapsed/refractory multiple myeloma (IberCd): ICON STUDY |
| Phase | Phase 2 |
| Therapy | Iberdomide combined with low-dose cyclophosphamide and dexamethasone |
| Objectives | Efficacy, safety |
| Population | Relapsed/refractory multiple myeloma, 2-4 prior lines |
| Status | Open |
| Reference | https://clinicaltrials.gov/ct2/show/NCT04392037 |
| Participants | ASZ, van Weel Bethesda, Ikazia, MaasstadZH, AMC, Radboudumc, Rijnstate |
| Short name | LAVA |
| Title |
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 |
| Phase | Phase 1 |
| Therapy | LAVA-051, Gammabody: activates Vγ9Vδ2 T cells and type 1 NKT cells targeting CD1d expressing MM (CLL/AML) |
| Objectives | Safety |
| Population | Subjects with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies |
| Status | Open |
| Reference |
https://www.hematologie-wijzer.nl/home/studieprotocollen/cll |
| Participants | Amsterdam UMC - AMC (A. Kater) Amsterdam UMC - VUmc (N. van de Donk) ErasmusMC (A. Broijl) |
| Short name | Gen3014-01 |
| Title | GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies |
| Phase | Phase 1/2 |
| Therapy | GEN3014 (HexaBody®-CD38) |
| Objectives | Safety, dose escalation and expansion phase |
| Population | 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 |
| Reference | https://clinicaltrials.gov/ct2/show/NCT04824794 |
| Participants |
UMCU (dr. Minnema) |
| Short name | LYNX |
| Title | 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 |
| Phase | Phase 2 |
| Therapy | Dara-Kd vs Kd |
| Objectives | Efficacy, safety |
| Population | Relapsed/refractory multiple myeloma, Previously Treated With Daratumumab, 1-3 prior lines |
| Status | Open |
| Reference | https://clinicaltrials.gov/ct2/show/NCT03871829 |
| Participants | ASZ, van Weel Bethesda, Ikazia, MaasstadZH |
AL amyloidosis
| Short name | EMN22 |
| Title | Phase 2 study of Daratumumab monotherapy in previously untreated patients with 3B light chain (AL) amyloidosis |
| Phase | Phase 2 |
| Therapy | Daratumumab monotherapy |
| Objectives | Overall survival (OS) rate at 6 months, ORR, VGPR and CR rate |
| Population | Previously untreated patients with 3B light chain (AL) amyloidosis |
| Eligibility |
Eligibility criteria in protocol |
| Status | Open |
| Reference | |
| Participants | UMC Utrecht, Prof Dr MC Minnema |