Myeloma Associated studies

Short name IsKia trial (EMN24/HOVON503)
Title 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)
Phase Phase III
Therapy Isatuximab-KRd vs KRD
Objectives Efficacy: PFS and MRD post-consolidation
Population Subjects with newly diagnosed multiple myeloma who are transplant eligible
Eligibility Eligibility criteria in protocol
Status Planned open Q1 2021
Reference https://clinicaltrials.gov/ct2/show/record/NCT04483739
Participants

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

Short name Anti GPRC5D duobody studie
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 N. van de Donk. UMCU, prof. M.C. Minnema
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 1/2a
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

Short name DREAMM-3
Title 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)
Phase Phase 3
Therapy Belantamab Mafodotin (anti-BCMA antibody) 
Objectives Efficacy and Safety
Population Relapsed/Refractory Multiple Myeloma
Eligibility Eligibility criteria in protocol
Status Open in Erasmus MC
Reference https://clinicaltrials.gov/ct2/show/NCT04162210
Participants EMC Rotterdam: Dr. A. Broijl
Short name DREAMM-5
Title 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).
Phase Phase I/II
Therapy GSK2857916 (Belantamab Mafodotin)
Objectives Safety and efficacy
Population RRMM
Eligibility Eligibility criteria in protocol
Status Open
Reference https://clinicaltrials.gov/ct2/show/NCT04126200
Participants

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

Short name DREAMM-7
Title 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
Phase Phase 3
Therapy Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd)
Objectives Efficacy and Safety
Population 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
Reference https://clinicaltrials.gov/ct2/show/NCT04246047
Participants

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

Short name KarMMa studie (Celgene bb2121-MM-003 (KarMMa-3)
Title 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).
Phase Phase 3
Therapy CAR-T cell bb2121 (targeting BCMA)
Objectives Efficacy and Safety
Population Relapsed and Refractory Multiple Myeloma
Eligibility Eligibility criteria in protocol 
Status Open
Reference https://clinicaltrials.gov/ct2/show/NCT03651128
Participants

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

Short name Cartitude-4
Title 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
Phase Phase 3
Therapy CAR-T directed against BCMA 
Objectives Efficacy
Population RRMM
Eligibility Eligibility criteria in protocol
Status Open in UMCU and AMC, not open yet in EMC
Reference https://clinicaltrials.gov/ct2/show/NCT04181827
Participants

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

Short name AMG701
Title 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)
Phase Phase I/2
Therapy AMG 701 BITE
Objectives Safety and tolerability
Population RRMM patients
Eligibility Eligibility criteria in protocol
Status Open
Reference https://clinicaltrials.gov/ct2/show/NCT03287908
Participants

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

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 TECLIMMY1001-P3 (part 3, expansion at RP2D)
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.
This specific study concerns Part 3 (Phase 2, dose expansion, sc.) Focused TECLIMMY1001-Part 3 (BCMAxCD3) Teclistamab

Phase Phase 2
Therapy Teclistamab sc.
Objectives Efficacy, ORR
Population 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
Reference https://clinicaltrials.gov/ct2/show/NCT04557098
Participants ErasmusMC, drs. Wester/dr. Broijlk

Smouldering multiple myeloma

Short name HOVON147/EMN015
Title Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma: A Randomized Phase II Study.
Phase Phase 2
Therapy KRd vs Kd
Objectives Efficacy, MRD and PFS
Population Patients with high-risk smouldering multiple myeloma, according to Pethema and/or Mayo criteria
Eligibility Eligibility criteria in protocol
Status Open
Reference https://clinicaltrials.gov/ct2/show/NCT03673826
Participants

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

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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