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
Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT)
Eligibility criteria in protocol

Status Open
Informatie https://clinicaltrials.gov/ct2/show/NCT04923893
Deelnemers AmsterdamAMC/ EMC/UMCG

 

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
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 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 Phase 3
Therapie  Tec-Dara vs DPD or DVd
Doelstellingen Efficacy (PFS)
Populatie 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
Referentie https://clinicaltrials.gov/ct2/show/NCT05083169
Deelnemers RadboudUMC
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
Part 2:  >1 PL, niet dara-refractair

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
MRD measured by NGS (central lab)

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
UMC Utrecht: Prof Dr M.C. Minnema,
MUMC: J. van Elssen)

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

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

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

Status Open
Referentie  
Deelnemers UMC Utrecht, Prof Dr MC Minnema
Up