Clinical Trials Actively Recruiting

Objective:
Primary Objective:

• To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients.

Secondary Objectives of First Randomization:

• To compare the best overall response rate (ORR), including partial remission (PR), very good partial remission (VGPR), and complete remission (CR, sCR) in the subset of patients not in PR at randomization to lenalidomide versus lenalidomide + daratumumab/rHuPH20 in this patient population.
• To compare progression-free survival (PFS) between the study arms in this patient population.
• To evaluate MRD-negativity on the two treatment arms at randomization (Registration Step 2), and to compare MRD-negativity rate at 12, 24 (second randomization), 36, and 48 months after first randomization between lenalidomide and lenalidomide + daratumumab/rHuPH20 in this patient population.
• To compare toxicities and tolerability of long term therapy between the study arms.

Objectives of Second Randomization:

• To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide vs. discontinued lenalidomide from the time of second randomization in this patient population.
• To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide + daratumumab/rHuPH20 vs. discontinued lenalidomide + daratumumab/rHuPH20 from time of second randomization in this patient population.

Objective:

Objective:

Primary Objective:

• To compare overall survival in MCL patients in MRD-negative first complete remission (CR) who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone (without auto- HCT).

Secondary Objectives:

• To compare progression-free survival in MCL patients in MRDnegative CR who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone.
• To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive CR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.
• To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.
• To define the overall survival and progression-free survival at 2 and 5 years of MRD-negative PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.
• To define the overall survival and progression-free survival at 2 and 5 years of MRD-indeterminate patients who undergo auto-HCT followed by 3 years of maintenance rituximab.
• To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT.
• To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive (including MRD-positive CR and MRD-positive PR) prior to auto-HCT.

Objective:

Primary Objective:

• The primary objective of this trial is to compare the rate of CR and PR on Day 28 postrandomization between AAT and CS versus PTM and CS in patients with high-risk acute GVHD.

Secondary Objectives:

• Evaluate the duration of response at 6 and 12 months post-randomization.
• Cumulative incidence of non-relapse mortality at 6 and 12 months post-randomization.
• Overall survival and progression-free survival at 6 and 12 months post-randomization.
• GVHD-free survival at Day 56 post-randomization.
• Proportions of CR, very good partial response (VGPR), PR, and treatment failure (TF) at Day 7, 14, 21, 28, 56, and 86 post-randomization.
• Incidence of systemic infections to assess safety.
• Incidence of Adverse Events at 30 days post last dose of drug to assess safety.
• Incidence of chronic GVHD at 6 and 12 months post-randomization and stem cell infusion (Day 0 HCT).
• Incidence of disease relapse at 6 and 12 months post-randomization.

Objective:

Primary objective:

• Assess the adherence rate of the use of the MyFitnessPal smartphone app during the second phase of trial participation in patients with amyloidosis.

Exploratory objectives:

• Explore associations between patient characteristics (demographics, health literacy, clinical characteristics, and perceptions) and the adherence during the second phase of trial participation.
• Explore the association between the adherence during the second phase of trial participation and subsequent adherence.

Objective:

AB-101 as Monotherapy

Primary Objectives:

• To evaluate the safety of AB-101 as monotherapy when administered to patients with relapsed/refractory (R/R) NHL of B-cell origin.

Secondary Objectives:

• To describe the clinical activity of AB-101 as monotherapy when administered to patients with R/R NHL of B-cell origin.

AB-101 Combination with Rituximab

Primary Objectives:

• To evaluate the safety and potential clinical activity of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin. Identify the recommended Phase 2 dose (RP2D)

Secondary Objectives:

• To evaluate additional endpoints for clinical activity of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin.
• AB-101 Combination with Rituximab – Phase 2

Primary Objectives:

• To determine the efficacy profile of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin.

Secondary Objectives:

• To evaluate additional endpoints to determine the efficacy profile of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin.
• To determine the safety profile of AB-101 in combination with rituximab when administered to patients with R/R NHL of B-cell origin.

Objective:

Part 1: Dose Escalation

Primary Objectives:

• To evaluate the safety and tolerability of BGB-11417 in combination with dexamethasone and dexamethasone plus carfilzomib in patients with relapsed/refractory (R/R) multiple myeloma (MM) and t(11;14)
• To determine the maximum tolerated dose/maximum assessed dose for BGB-11417 in combination with dexamethasone in patients with R/R MM and t(11;14)
• To determine the recommended Phase 2 dose (RP2D) of BGB-11417 in combination with dexamethasone to be used in Part 2 (cohort expansion)
• To determine the recommended dose for the combination of BGB-11417 plus dexamethasone plus carfilzomib to be used in Part 2

Secondary Objective:

• To assess the pharmacokinetics of BGB-11417 in combination with dexamethasone and with dexamethasone plus carfilzomib

Exploratory Objectives:

• To estimate the overall response rate of BGB-11417 in combination with dexamethasone and with dexamethasone plus carfilzomib in patients with R/R MM and t(11;14)
• To assess the pharmacokinetics of dexamethasone in combination with BGB-11417

Part 2: Cohort Expansion

Primary Objectives:

• To evaluate the safety and tolerability of BGB-11417 at the recommended Phase 2 dose as monotherapy and in combination with dexamethasone in patients with R/R MM and t(11;14)
• To evaluate the safety and tolerability of BGB-11417 in combination with dexamethasone plus carfilzomib at the recommended dose for the combination therapy in patients with R/R MM and t(11;14)
• To evaluate the efficacy of BGB-11417 as monotherapy, in combination with dexamethasone, and with dexamethasone plus carfilzomib in patients with R/R MM and t(11;14) as measured by overall response rate and additional response rates

Secondary Objective:

• To evaluate the efficacy of BGB-11417 as monotherapy, in combination with dexamethasone, and with dexamethasone plus carfilzomib in patients with R/R MM and t(11;14) as measured by duration of response, time to response, and time-to-event outcomes

Exploratory Objectives:

• To explore the correlation between biomarker characteristics and efficacy outcomes
• To evaluate the efficacy of BGB-11417 as measured by minimal residual disease
• To explore the association between biomarker characteristics and resistance to BGB-11417
• To further evaluate the pharmacokinetics of BGB-11417 when given as monotherapy, in combination with dexamethasone, and with dexamethasone plus carfilzomib

Objective:

Primary Objectives:

Cohort 1:

• to characterize cardiac safety of different D-VCd treatment regimens (Arm A: immediate daratumumab + VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic AL amyloidosis with cardiac involvement and to identify potential mitigation strategies (monitoring of cardiac health/performance via ECG, echocardiography [ECHO], 6 min walk test, biomarkers [TroponinT, HS TroponinT, and NT-proBNP] to inform clinical mitigation strategies alongside comparison of different treatment schedules) for cardiac toxicity.

Cohort 2:

• To characterize the PK of SC daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed systemic AL amyloidosis treated with D-VCd.

Secondary Objectives:

• To evaluate efficacy measures
• To assess the safety profile, including cardiac events
• To characterize the PK of SC daratumumab
• To assess the immunogenicity of SC daratumumab
• To monitor the clinical signs and symptoms of cardiac AL amyloidosis to identify possible predictive factors for cardiac events

Objective:

Primary Objective:

• To investigate the safety of repeated dosing of TSC-100 and TSC-101 in HLA-A*02:01 positive participants undergoing haploidentical allogeneic peripheral blood stem cell transplantation and determine the optimally tolerated dose range

Secondary Objectives:

• To investigate the efficacy of TSC-100 and TSC-101 combined with the SOC compared with that of the SOC alone in participants undergoing haploidentical allogeneic peripheral blood stem cell transplantation
• To assess the immunogenicity of TSC-100 and TSC-101

Objective:

Part 1: Phase 1 Dose Escalation Phase

Primary Objective:

• To evaluate the safety and maximum tolerated dose (MTD) of EZM0414 when administered as monotherapy in subjects with relapsed/refractory (R/R) multiple myeloma (MM) and R/R diffuse large B cell lymphoma (DLBCL).

Exploratory Objectives:

• To investigate target engagement in samples collected before and during treatment with EZM0414.
• To determine exploratory biomarkers such as histones and histone methylation, somatic mutations, DNA methylation, DNA alterations such as t(4;14) and others, protein levels, RNA expression, and immune cells in bone marrow aspirates, tumor biopsies, and blood samples.
• To assess pharmacokinetics (PK) of EZM0414 when administered as monotherapy in subjects with R/R MM and R/R DLBCL.

Part 2: Phase 1b Dose Expansion Phase

Primary Objectives:

• To determine the safety and tolerability of EZM0414 in subjects with R/R MM and R/R DLBCL.
• To establish the recommended Phase 2 dose (RP2D).

Secondary Objectives:

• To determine the efficacy of EZM0414 as demonstrated by the effect on objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR) in subjects with R/R MM and R/R DLBCL.

Exploratory Objective:

• To determine H3K36me3 in tumor tissue biopsy/bone marrow biopsy and blood samples.
• To determine exploratory biomarkers such as histones and histone methylation, somatic mutations, DNA methylation and other DNA alterations such as t(4;14) and others, protein levels, RNA expression, and immune cells in bone marrow aspirates, tumor biopsies, and blood samples.
• To determine the pharmacokinetic profile of EZM0414.