8 results
  • A Long-Term Study for Participants Previously Treated With Ciltacabtagene Autoleucel. - NCT05201781

    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.

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    • Protocol Number:
      012204

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Matthew Matasar

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
    • Participants who have provided informed consent for this study

    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.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy. - NCT05455320

    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.

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    • Protocol Number:
      012301

    • Principal Investigator:
      Mansi Shah MD

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Talquetamab DEXAMETHASONE Pomalidomide Daratumumab

      • Contacts:

      • Rutgers University Prinicipal Investigator: Mansi Shah MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
    • Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
    • Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
    • Documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or after their last regimen
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment

    Exclusion Criteria:

    • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
    • Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
    • Received prior pomalidomide therapy
    • A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug
    • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
    • Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis

    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.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination with Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease - NCT05263999

    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.

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    • Protocol Number:
      012313

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Itolizumab/Placebo

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Amer Assal MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study. 2. Is age ≥12 years and >40kg at informed consent/assent. 3. Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis. 4. Has evidence of myeloid engraftment 5. Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria. 6. Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.

    Exclusion Criteria:

      1. Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast. 2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT. 3. Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT. 4. Evidence of cGVHD or overlap syndrome 5. Use of immunosuppressants other than corticosteroids for the treatment of aGVHD. 6. Use of any systemic corticosteroids of >0.5 mg/kg/day methylprednisolone or equivalent for any indication other than aGVHD within 7 days before the onset of aGVHD.

    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.

    • Rutgers Cancer Institute of New Jersey
  • Individual Patient Expanded Access for Nonconforming BMS CAR T Cell Therapy

    The objective of this trial is to treat patient Patient ENR-007072 with ABECMA drug product Lot R2R1-WH174J

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    • Protocol Number:
      012323

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Multiple Myeloma

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Amer Assal MD
    • Rutgers Cancer Institute of New Jersey
  • Machine Learning-based High-throughput and Integrative Immunological Synapse Quality Evaluation As a Composite Biomarker for Predicting CAR Therapy Efficacy in Immuno-Oncology.

    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.

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    • Protocol Number:
      012108

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Multiple Myeloma,Hodgkin's Lymphoma,Non-Hodgkin's Lymphoma

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Yun Kyoung Tiger
    • Rutgers Cancer Institute of New Jersey
  • Phase 1/2 Study of Linvoseltamab (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Previously Untreated Patients with Symptomatic Multiple Myeloma (Linker-MM4 Study) - NCT05828511

    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

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    • Protocol Number:
      012310

    • Principal Investigator:
      Mansi Shah MD

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Linvoseltamab (REGN5458)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Mansi Shah MD

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

      1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 2. Confirmed diagnosis of symptomatic multiple myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria 3. Measurable disease, according to the 2016 IMWG response criteria, as defined in the protocol 4. No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol 5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol 6. Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance.

    Key Exclusion Criteria:

      1. Receiving any concurrent investigational agent with known or suspected activity against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/ Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis 2. Known central nervous system (CNS) involvement with MM, known or suspected progressive multifocal leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment 3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy 4. Diagnosis of non-secretory MM, active plasma cell leukemia, primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) Note: Other protocol-defined Inclusion/Exclusion criteria apply

    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.

    • Rutgers Cancer Institute of New Jersey
  • Testing of Immune Synapse Characteristics During Therapy of Multiple Myeloma

    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.

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    • Protocol Number:
      012322

    • Principal Investigator:
      Mansi Shah MD

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Multiple Myeloma

      • Contacts:

      • Rutgers University Prinicipal Investigator: Mansi Shah MD
    • Rutgers Cancer Institute of New Jersey
  • The Prophylactic Use of Loratadine for Granulocyte-Colony Stimulating Factor (G-CSF) Induced Bone Pain in Multiple Myeloma Patients Undergoing Stem Cell Mobilization. - NCT04211259

    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.

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    • Protocol Number:
      011910

    • Principal Investigator:
      Mansi Shah MD

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Multiple Myeloma,Ill-Defined Sites,Bones and Joints

    • Therapies Involved:
      Chemotherapy (NOS) Chemotherapy multiple agents systemic

    • Drugs Involved:
      Loratadine/Placebo Pegfilgrastim

      • Contacts:

      • Rutgers University Prinicipal Investigator: Mansi Shah MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patient must be able to provide informed consent
    • Patients with confirmed diagnosis of multiple myeloma
    • Able to swallow and retain oral medication
    • All ethnic groups are eligible

    Exclusion Criteria:

    • Non-English speaking person
    • Patients undergoing haploidentical allogeneic hematopoietic stem cell transplant
    • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
    • Any medical complications or conditions that would, in the investigator's judgement, interfere with full participation in the study
    • On therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study

    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.

    • Rutgers Cancer Institute of New Jersey