Myeloma Associated studies

 

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 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 III
Therapy Tec-Dara vs DPD or DVd
Objectives Efficacy (PFS)
Population RRMM patients
Eligibility Relapsed / refractory MM as defined by Durie et al
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 Open
Reference https://clinicaltrials.gov/ct2/show/NCT05083169
Participants RadboudUMC
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 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
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 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 Not open yet
Reference https://clinicaltrials.gov/ct2/show/NCT05317416
Participants

MUMC

Short name TEG studie
Title A phase I study to investigate the safety and tolerability of TEG001 cell suspension for infusion in patients with relapsed/refractory AML or high risk MDS (IPSS > 4.5) or relapsed/refractory MM.
Phase Phase I
Therapy TEG001 cell suspension
Objectives Safety and tolerability
Population RRMM patients (including plasma cell leukemia)
Eligibility Relapsed / refractory MM as defined by Durie et al
Relapsed from, or refractory to, 2 or more different prior therapies
Relapse post allo-HSCT but no active GvHD and/or systemic immune suppression
Eligibility criteria in protocol
Status Open
Reference https://www.trialregister.nl/trial/6357
Participants

UMC Utrecht, Dr. M de Witte

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, AMC
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
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

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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