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Infusion of mesenchymal stem cells as treatment for steroid resistant grade II to IV acute GVHD or poor graft function: a multicenter phase II study

This is a mulricenter phase II study examining the feasability and efficacy of this approach. Subjects will receive by intraveneus infusion a dose of MSC (aiming for 2 x 106/kg or highest avialable dose)

An open label extension study to evaluate the safety of long term dosing of AMG 531 in trombocytopenic subjects with myelodysplastic syndromes (MDS).

To provide long-term safety data for the use of AMG 531 in thrombocytopenic subjects with IPSS low or intermediate-1 risk MDS.

Safety and efficacy of interleukin-1 inhibitor anakinra for the amelioration of fever during neutropenia and mucositis in patients with multiple myeloma receiving an autologous hematopoietic stem cell transplantation after high-dose melphalan

The primary objective is to evaluate the safety and efficacy of anakinra in patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (SCT). Secondary objectives…

A Phase Ib/II, open-label, multi-center, dose-finding study to assess the safety and efficacy of the oral combination of LDE225 and INC424 (Ruxolitinib) in patients with myelofibrosis

To establish the MTD and/or recommended phase II dose of the coadministration of LDE225 and INC424 in patients with MF, who have not previously received therapy with a JAK inhibitor

A Phase I/II study of Azacitidine (Vidaza®) in pediatric patients with relapsed high-grade pediatric MDS or JMML

Primary ObjectivesThe current study aims to establish the recommended dose, safety and preliminary efficacy of azacitidine administered IV or SC in children with relapsed/refractory MDS or JMML, in 2 different subgroups (strata) of patients.…

A Phase 1b-2, Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Relapsed or Refractory Multiple Myeloma

Primary objective: To evaluate the efficacy of JNJ-68284528 (Phase 2)Secondary objectives:# To characterize the safety of JNJ-68284528 (Phase 2)# To characterize the pharmacokinetics and pharmacodynamics of JNJ-68284528# To assess the immunogenicity…

A Phase 1/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 Monotherapy, or in Combination with Pomalidomide, with and without Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma (ParadigMM-1B)

Phase 1 - AMG 701 dose-exploration as monotherapyPrimary Objectives:• Evaluate the safety and tolerability of AMG 701 in subjects with relapsed/refractory multiple myeloma (RRMM) to determine the maximum tolerated dose (MTD) and/or recommended phase…

A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma

This study has been transitioned to CTIS with ID 2023-506587-13-00 check the CTIS register for the current data. The safety and efficacy of JNJ-68284528 in heavily pretreated patients with multiple myeloma is being evaluated in the Phase 1b/2 Study…

A Phase 2 Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Narsoplimab in Paediatric Patients (28 Days to 18 Y.O.) with High Risk Haematopoietic Stem Cell Transplant Thrombotic Microangiopathy

This study has been transitioned to CTIS with ID 2023-509710-11-00 check the CTIS register for the current data. Study Objectives:The purpose of this Phase 2 study is to evaluate the safety, efficacy, pharmacokinetics (PK),pharmacodynamics (PD), and…

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

This study has been transitioned to CTIS with ID 2023-504581-29-00 check the CTIS register for the current data. Primary* Part 1 (Dose Escalation): To characterize the safety of JNJ-64407564 and recommend thePhase 2 dose(s) and schedule* Part 2 (…

A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination with Bispecific T Cell Redirection Antibodies for the Treatment of Subjects with Multiple Myeloma

This study has been transitioned to CTIS with ID 2023-503468-17-00 check the CTIS register for the current data. Primary- Part 1: To identify recommended Phase 2 doses and schedules (RP2Ds) for each combination.- Part 2: To characterize the safety…

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 study has been transitioned to CTIS with ID 2023-503438-40-00 check the CTIS register for the current data. Primary: - Part 1 (Dose Escalation): To identify the recommended Phase 2 dose(s) and schedule assessed to be safe for teclistamab - Part…

A Phase 3, 52-week, open-label, single arm study to investigate the efficacy and safety of mepolizumab SC in participants aged 6 to 17 years with hypereosinophilic syndrome.

This study has been transitioned to CTIS with ID 2023-510110-36-00 check the CTIS register for the current data. Primary objective: To evaluate the efficacy of mepolizumab SC given every 4 weeks in participants aged 6 to 17 years with HESSecondary…

A Phase I, first-in-human, multicenter, open-label, dose escalation followed by an expansion phase clinical study of KBA1412 given as monotherapy or in combination with pembrolizumab in adults with
advanced solid malignant tumors

DOSE ESCALATION PHASE: PART A: Primary Objectives: • To assess the safety and tolerability of KBA1412 when given as monotherapy. • To determine the maximum tolerated dose (MTD) and/or Recommended Phase II dose (RP2D) of KBA1412 when given as…

Positron emission tomography with innovative laboratory techniques for improved risk and disease assessment in myeloma

The aim of this project is to validate 3 novel biomarkers (FDG PET/CT, WES and NGF). The utilization goal is to implement these biomarkers afterwards in clinical practice to rationalize treatment strategies. The primary objective is to validate the…

A Phase 1/2, open-label, 2-arm study evaluating BLU-263 as monotherapy and in combination with azacitidine, in patients with KIT altered hematologic malignancies

This study has been transitioned to CTIS with ID 2023-510144-20-00 check the CTIS register for the current data. The current study is designed to evaluate the preliminary safety and efficacy of BLU-263 in patients with AdvSM, including in those with…

A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants with Multiple Myeloma

This study has been transitioned to CTIS with ID 2023-503620-60-00 check the CTIS register for the current data. The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination…

A Four-Part, Open Label, Randomized, Parallel Assignment Study to Evaluate the Pharmacodynamics of Nirogacestat on B-Cell Maturation Antigen (BCMA)

Part 1In Part 1 of the study, no study compound will be administered, but a bone marrow aspiration and a blood sample will be taken to evaluate an assay that will be used for Part 2 and Part 3 of the study. Because no nirogacestat is given, we can…

Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants with Relapsed or Refractory Multiple Myeloma

This study has been transitioned to CTIS with ID 2023-503679-12-00 check the CTIS register for the current data. Part 1 (Dose Escalation) - to identify the recommended Phase 2 dose(s) and schedule(s) to be safe for JNJ-79635322. Part 2 (Dose…

A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma

Primary Objective- To evaluate if daratumumab can effectively decrease M protein in subjects with intermediate or high-risk SMM as assessed by CR rate- To determine if daratumumab reduces the progression/death rate in subjects with intermediate or…