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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.
For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.
To evaluate the overall minimal residual disease (MRD) negative rate of subjects who receive JNJ-68284528.
Protocol Number: 011909
Principal Investigator: Mansi Shah MD
Phase: Phase II
Drugs Involved: JNJ-68284528
Primary: - To evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT. Secondary: - To further evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT and 3 prior LOT.
Protocol Number: 012402
Therapies Involved: Chemotherapy single agent systemic
Drugs Involved: BMS-986393
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
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
Drugs Involved: Itolizumab/Placebo
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: 1. To assess the preliminary anti-tumor activity of linvoseltamab in participants with NDMM who are eligible for HDT with ASCT (transplant-eligible) 2. To assess the preliminary anti-tumor activity of linvoseltamab in participants with NDMM who are ineligible for ASCT (transplant-ineligible)
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
Scope: Local
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
Applicable Disease Sites: Multiple Myeloma,Ill-Defined Sites,Bones and Joints
Therapies Involved: Chemotherapy (NOS) Chemotherapy multiple agents systemic
Drugs Involved: Loratadine/Placebo Pegfilgrastim