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To collect long-term follow-up data on delayed adverse events after administration of cilta-cel, and to characterize and understand the long-term safety profile of cilta-cel.
Protocol Number: 012204
Phase: N/A
Scope: National
Applicable Disease Sites: Multiple Myeloma
Contacts:
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Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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The primary objective of this study is to compare the efficacy of talquetamab SC in combination with daratumumab SC and pomalidomide (Tal-DP; Arm A) and talquetamab SC in combination with daratumumab SC (Tal-D; Arm C) with that of daratumumab SC in combination with pomalidomide and dexamethasone (DPd; Arm B) as assessed by PFS, respectively.
Protocol Number: 012301
Principal Investigator: Mansi Shah MD
Phase: Phase III
Therapies Involved: Chemotherapy multiple agents systemic
Drugs Involved: Talquetamab DEXAMETHASONE Pomalidomide Daratumumab
Primary Objective To assess the efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response. Secondary Objectives To evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids. To evaluate systemic corticosteroid use in subjects treated with itolizumab versus placebo. To assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures, including survival outcomes and cGVHD incidence. To evaluate the safety and tolerability of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids. Exploratory Objectives To evaluate the impact of itolizumab versus placebo on health-related quality of life in subjects with aGVHD. To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) properties of itolizumab in subjects with aGVHD. To assess changes in biomarker expression following treatment with itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.
Protocol Number: 012313
Therapies Involved: Chemotherapy single agent systemic
Drugs Involved: Itolizumab/Placebo
The objective of this trial is to treat patient Patient ENR-007072 with ABECMA drug product Lot R2R1-WH174J
Protocol Number: 012323
Scope: Local
1. The primary objective is to determine if a novel fluorescent assay measuring dynamic parameters of immune synapse quality can be used to assess commercial T cell products. 2. The secondary objective is to determine if a novel fluorescent assay measuring dynamic parameters of the immune synapse can be used as a biomarker to associate with CAR-T cell efficacy and toxicity.
Protocol Number: 012108
Applicable Disease Sites: Multiple Myeloma,Hodgkin's Lymphoma,Non-Hodgkin's Lymphoma
Primary: For phase 1, the primary objective of the study is to assess the safety, tolerability, and to determine a recommended phase 2 dose regimen (RP2DR) of linvoseltamab for phase 2 of the study. For phase 2, the primary objectives of the study are: To assess the preliminary anti-tumor activity of linvoseltamab in participants with NDMM who are eligible for HDT with ASCT (transplant-eligible) To assess the preliminary anti-tumor activity of linvoseltamab in participants with NDMM who are ineligible for ASCT (transplant-ineligible) The secondary objectives of the study are: For phases 1 and 2 (applicable to both cohorts [ie, transplant-eligible and transplant-ineligible]): To evaluate the pharmacokinetic (PK) properties of linvoseltamab To evaluate total soluble BCMA concentrations in serum at baseline and over time To assess the immunogenicity of linvoseltamab For phase 1: To assess the preliminary anti-tumor activity of linvoseltamab For phase 2 (applicable to both cohorts): To evaluate the safety and tolerability of linvoseltamab To evaluate the preliminary anti-tumor activity of linvoseltamab in participants who are transplant-eligible and transplant-ineligible Transplant-eligible cohort only: To evaluate duration of response (DOR), PFS, and rate of minimal residual disease (MRD) negative status after ASCT To evaluate the impact of therapy with single-agent linvoseltamab on the ability to collect stem cells in any participants who subsequently undergo stem cell mobilization To evaluate the kinetics of engraftment To evaluate the overall PFS Transplant-ineligible cohort only To evaluate DOR, PFS, and rate of MRD-negative status
Protocol Number: 012310
Phase: Phase I/II
Drugs Involved: Linvoseltamab (REGN5458)
1. The primary objective is to determine if a novel fluorescent assay that measures dynamic parameters of immune synapse quality can be used for real-time assessment of the immune synapse between immune cells and target antigens during the course of MM therapy and compare them with normal controls i.e. subjects with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The immune cells will be autologous T cells targeting will be mediated via a BITE. 2. The secondary objectives are to determine if this novel fluorescent assay should be developed for use as a biomarker to (i) prospectively assess the clinical efficacy and toxicity of a T-cell engager; and/or (ii) determine the sequencing of specific BITE therapies in the course of anti-myeloma therapy; and/or (iii) determine the functionality of the assay by evaluating the T-cell reactivity of subjects with MGUS and SMM who are not on treatment.
Protocol Number: 012322
The primary objective of this study is to evaluate the efficacy of the second-generation antihistamine, loratadine, as prophylaxis for filgrastim (i.e., Neupogen, Zarxio) induced bone pain during stem cell mobilization in multiple myeloma patients. The secondary objectives are to (1) examine the frequency and quantity of supportive analgesic medications needed in addition to loratadine or placebo for filgrastim induced bone pain and (2) identify risk factors associated with developing filgrastim induced bone pain.
Protocol Number: 011910
Phase: Phase II
Applicable Disease Sites: Multiple Myeloma,Ill-Defined Sites,Bones and Joints
Therapies Involved: Chemotherapy (NOS) Chemotherapy multiple agents systemic
Drugs Involved: Loratadine/Placebo Pegfilgrastim