Myeloma Associated studies

Short name EMN28/Cartitude-6/EM-agine
Title 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
Phase Phase 3
Therapy Dara-VRD/HDM/ASCT vs DaraVRD/CAR-T
Objectives Efficacy (PFS) en safety
Population NDMM TE patients
Eligibility NDMM transplant eligible
Status Open
Information EMN 33 - European Myeloma Network 
Participants EMC, Amsterdam UMC, UMCU, UMCG, Radboud UMC
Short name EMN33/ TAURUS
Title 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
Phase Phase 2
Therapy Dara-VRD, HDM/ASCT. Gebuik makend van bloodbased MRD
Objectives Efficacy (PFS) en safety
Population NDMM TE patients
Eligibility NDMM transplant eligible
Status Open
Information EMN 33 - European Myeloma Network
Participants Many hospitals in the Netherlands, inform at a centre near you
Short name EMN30/ MAJESTEC-4
Title 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
Phase Fase 3, onderhoud
Therapy Teclistamab/ Lenalidomide vs. Teclistamab vs. Lenalidomide
Objectives Efficacy (PFS) en safety
Population NDMM TE patients
Eligibility NDMM transplant eligible
Status Open
Information EMN30 - European Myeloma Network
Participants EMC, Amsterdam UMC, UMCG, ASZ, and other centres, inform at a centre near you
Short name MAGNETISMM-6
Title 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
Phase Fase 3
Therapy Elranatamab + daratumumab + lenalidomide (EDR) versus Daratumumab + lenalidomide + dexamethasone (DRd)
Objectives Efficacy (PFS) en safety
Population NDMM TIE patients
Eligibility NDMM transplant ineligible
Status Open
Information https://clinicaltrials.gov/study/NCT05623020
Participants VieCuri, ASZ
Short name Excaliber-maintenance
Title 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
Phase Fase 3, onderhoud
Therapy Iber vs len onderhoud na autoPSCT
Objectives Efficacy (PFS) en safety
Population NDMM TE patients, onderhoud
Eligibility NDMM transplant eligible
Status Open
Information https://clinicaltrials.gov/study/NCT05317416
Participants ASZ, Amsterdam UMC
Short name MAJESTEC-7
Title 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
Phase Fase 3
Therapy Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR)
Objectives Efficacy (PFS) en safety
Population NDMM TE patients
Eligibility NDMM transplant eligible
Status Open
Information https://clinicaltrials.gov/study/NCT05552222
Participants Amsterdam UMC, Antonius
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
MRD measured by NGS (central lab)

Eligibility Eligibility criteria in protocol
Status Open in HAGAZH
Information https://clinicaltrials.gov/ct2/show/NCT05317416
Participants MUMC/HAGAZH
Short name EMN 29
Title 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
Phase Phase 3
Therapy SPd versus EPd
Objectives Efficacy (PFS) en safety
Population RRMM patients
Eligibility

Relapsed/refractory MM, received at least 1 and no more than 4 lines of prior anti-MM regimens.
Eligibility criteria in protocol

Status Open
Information https://clinicaltrials.gov/ct2/show/NCT05028348
Participants EMC, Amphia ziekenhuis
Short name Majestec-3
Title 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
Phase Phase 3
Therapy Tec-Dara vs DPD or DVd
Objectives Efficacy (PFS)
Population 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 Closed for inclusion
Information https://clinicaltrials.gov/ct2/show/NCT05083169
Participants RadboudUMC, UMCG
Short name Majestec-9
Title 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
Phase Phase 3
Therapy TEC vs Kd or PVD
Objectives Efficacy (PFS)
Population 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
Information https://clinicaltrials.gov/study/NCT05572515
Participants UMCU, UMCG, Amsterdam UMC
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
Information https://clinicaltrials.gov/study/NCT03399799
Participants MUMC, EMC
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

Amsterdam UMC

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 Closed for inclusion
Information https://clinicaltrials.gov/ct2/show/NCT04108195
Participants AmsterdamAMC
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

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
UMC Utrecht; Prof Dr M.C. Minnema

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 UMCU, MUMC, UMCG
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
Part 2:  >1 PL, niet dara-refractair

Eligibility Eligibility criteria in protocol
Status Not open yet
Reference https://clinicaltrials.gov/ct2/show/NCT05020236
Participants

MUMC / ErasmusMC

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
UMC Utrecht: Prof Dr MC Minnema
MUMC: J van Elssen

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, Amsterdam UMC, 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 Closed
Reference

https://www.hematologie-wijzer.nl/home/studieprotocollen/cll
https://www.hematologie-wijzer.nl/home/studieprotocollen/mm
https://clinicaltrials.gov/ct2/show/NCT04887259

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)
ErasmusMC (A. Broijl)
MUMC (J. van Elssen)

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
Short name CA058-002
Title 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
Phase Phase 1b/2a
Therapy Alnuctamab/ Mezigdomide
Objectives Safety and tolerability
Population RRMM patients
Relapsed / refractory MM as defined by Durie et al
Eligibility Eligibility criteria in protocol
Status Open
Reference https://clinicaltrials.gov/study/NCT06163898
Participants UMCG/UMCU
Short name EMN34/ ERASMM
Title Phase 2 study for the Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
Phase Phase 2
Therapy Elranatamab monotherapy
Objectives Safety and efficacy
Population 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.
Ref: Myeloma Working Group risk stratification model for smouldering myeloma (SMM). Blood Cancer J. 2020;10(10):102. DOI: 1038/s41408-020-00366-3

Status Open
Reference https://clinicaltrials.gov/study/NCT06183489
Participants MUMC (dr van Elsen), Antonius ZH (dr Nijhof), ErasmusMC (dr. Broijl)

 

Short name 79635322MMY1001
Title A Phase 1 Study of JNJ-79635322 in Participants with Relapsed or Refractory Multiple Myeloma
Phase Phase 1
Therapy JNJ-79635322
Objectives Safety and tolerability
Population 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
Reference https://clinicaltrials.gov/study/NCT05652335
Participants Amsterdam UMC, UMCU

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
3B = increased trop T and NT pro BNP > 8500 pg/ml (or > 1000 pmol/L)

Status Open
Reference  
Participants UMC Utrecht, Prof Dr MC Minnema
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