Myeloma Associated studies

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
Status	Open
Information	https://www.hematologie-wijzer.nl/home/studieprotocollen/cll https://www.hematologie-wijzer.nl/home/studieprotocollen/mm
Participants	Amsterdam UMC - AMC (A. Kater) Amsterdam UMC - VUmc (N. van de Donk) ErasmusMC (A. Broijl)

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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