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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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. |
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) |
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) |
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 |
Status | Open |
Reference | |
Participants | UMC Utrecht, Prof Dr MC Minnema |