Myeloom geassocieerde studies

Naam IsKia trial (EMN24/HOVON503)
Titel Phase III study of Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone (Isa-KRd) versus Carfilzomib-Lenalidomide-Dexamethasone (KRd) in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation (IsKia TRIAL)
Fase Phase III
Therapie  Isatuximab-KRd vs KRD 
Doelstellingen Efficacy: PFS and MRD post-consolidation
Populatie Subjects with newly diagnosed multiple myeloma who are transplant eligible
Eligibility Eligibility criteria in protocol
Status Planned open Q1 2021
Referentie https://clinicaltrials.gov/ct2/show/record/NCT04483739
Deelnemers

ErasmusMC, dr. Broijl
Amsterdam UMC, prof. van de Donk.
UMCG, dr. Roeloffzen
Zuyderland Medical Center, dr. Jie
Haga Ziekenhuis, dr. Ypma
Noordwest Ziekenhuisgroep, dr. Westerman
Albert Schweitzer Hospital,  dr. Levin
Canisius Wilhelmina Hospital, dr. de Jonge (UMCN als transplantatiecentrum)
Amphia ZH, dr. van der klift
Meander Medisch Centrum, dr. Fijnheer/dr. Regelink (UMCU als transplantatiecentrum)
Medisch Centrum Leeuwarden, dr. de Waal
Maastricht Academic Hospital, prof. Bos
Antonius Nieuwegein, dr. Sohne

Naam 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 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 1/2a
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 MC Minnema

Naam DREAMM-3
Titel A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide plus Lowdose Dexamethasone (pom/dex) in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)(DREAMM 3) 
Fase Phase 3
Therapie  Belantamab Mafodotin (anti-BCMA antibody) 
Doelstellingen Efficacy and Safety
Populatie Relapsed/Refractory Multiple Myeloma
Eligibility Eligibility criteria in protocol
Status Not open yet
Referentie https://clinicaltrials.gov/ct2/show/NCT04162210
Deelnemers EMC Rotterdam: Dr. A. Broijl
Naam DREAMM-5
Titel A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study GSK2857916 as Monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM).
Fase Phase I/II
Therapie  GSK2857916 (Belantamab Mafodotin)
Doelstellingen Safety and efficacy
Populatie RRMM
Eligibility Eligibility criteria in protocol
Status Open
Referentie https://clinicaltrials.gov/ct2/show/NCT04126200
Deelnemers

UMC Utrecht: Prof. Dr. M.C. Minnema
Amsterdam UMC: Prof. dr. N. vd Donk 

Naam DREAMM-7
Titel A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma
Fase Phase 3
Therapie  Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd)
Doelstellingen Efficacy and Safety 
Populatie Relapse or refractory MM previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy.
Eligibility Eligibility criteria in protocol
Status Open
Referentie https://clinicaltrials.gov/ct2/show/NCT04246047
Deelnemers

UMC Utrecht: dr. M. Jak
Isala Oncologisch Centrum Zwolle: dr. E. Kneppers
Albert Schweitzer Ziekenhuis Dordrecht: M.D. Levin
UMC Groningen: dr. W.W.H. Roeloffzen
Maasstad ziekenhuis Rotterdam: dr. Y. Sandberg
St. Antonius Ziekenhuis Nieuwegein: dr. M. Söhne

Naam KarMMa studie (Celgene bb2121-MM-003 (KarMMa-3)
Titel Celgene bb2121-MM-003 (KarMMA-3). A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Triplet Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3).
Fase Phase 3 
Therapie  CAR-T cell bb2121 (targeting BCMA)
Doelstellingen Efficacy and Safety
Populatie Relapsed and Refractory Multiple Myeloma
Eligibility Eligibility criteria in protocol 
Status Open
Referentie https://clinicaltrials.gov/ct2/show/NCT03651128
Deelnemers

Amsterdam UMC: Prof. dr. N. v.d. Donk
EMC Rotterdam: Dr. A. Broijl

Naam Cartitude-4
Titel A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple Myeloma
Fase Phase 3
Therapie  CAR-T directed against BCMA 
Doelstellingen Efficacy
Populatie RRMM
Eligibility Eligibility criteria in protocol
Status Open in UMCU and AMC, not open yet in EMC
Referentie https://clinicaltrials.gov/ct2/show/NCT04181827
Deelnemers

EMC Rotterdam: Dr. A. Broijl
Amsterdam UMC: Prof. dr. N. v.d. Donk
UMC Utrecht; Prof Dr MC Minnema

Naam AMG701
Titel A Phase 1/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 in Subjects With Multiple Myeloma (ParadigMM-1B)
Fase Phase I/2
Therapie  AMG 701 BITE
Doelstellingen Safety and tolerability
Populatie RRMM patients
Eligibility Eligibility criteria in protocol
Status Open
Referentie https://clinicaltrials.gov/ct2/show/NCT03287908
Deelnemers

UMC Utrecht, Prof Dr MC Minnema
UMCG: Dr W Plattel

Naam TEG studie
Titel 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.
Fase Phase I
Therapie  TEG001 cell suspension
Doelstellingen Safety and tolerability
Populatie 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
Referentie https://www.trialregister.nl/trial/6357
Deelnemers UMC Utrecht, Dr. M de Witte
Naam TECLIMMY1001-P3 (part 3, expansion at RP2D)
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.
This specific study concerns Part 3 (Phase 2, dose expansion, sc.) Focused TECLIMMY1001-Part 3 (BCMAxCD3) Teclistamab

Fase Phase 2
Therapie  Teclistamab sc.
Doelstellingen Efficacy, ORR
Populatie RRMM patients (including plasma cell leukemia)
Eligibility

Depending cohort: at least 3 prior lines therapy, in cohort C only after anti-BCMA therapy (CAR-T/ADC)
Eligibility criteria in protocol

Status Not open yet
Referentie https://clinicaltrials.gov/ct2/show/NCT04557098
Deelnemers ErasmusMC, drs. Wester/dr. Broijl

Smouldering multiple myeloma

Naam HOVON147/EMN015
Titel Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma: A Randomized Phase II Study.
Fase Phase 2
Therapie  KRd vs Kd
Doelstellingen Efficacy, MRD and PFS
Populatie Patients with high-risk smouldering multiple myeloma, according to Pethema and/or Mayo criteria
Eligibility Eligibility criteria in protocol
Status Open
Referentie https://clinicaltrials.gov/ct2/show/NCT03673826
Deelnemers

ErasmusMC, dr. Broijl (PI)
Amsterdam UMC, prof. van de Donk
Medisch Centrum Leeuwarden, dr. de Waal
Jeroen Bosch ZH, dr. Issa
Zuyderland Medical Center, dr. Jie
Spaarne ZH, dr. Houtenbos


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
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