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  • 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

    • Principal Investigator:
      Matthew Matasar

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    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
  • A Phase 1/2 Study of ABBV-383 in Combination with Anti-Myeloma Agents for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma - NCT06896916

    Primary Objectives To characterize the safety, toxicity, and tolerability of etentamig when co-administered with iberdomide in subjects with RRMM. To determine the recommended doses of etentamig and iberdomide combination treatment in subjects with RRMM. Secondary Objectives To evaluate the preliminary anti-MM activity of etentamig when co-administered with Iberdomide. To characterize the PK and the immunogenicity of etentamig, as well as the PK of iberdomide and its metabolite M12, when administered in combination as a regimen.

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    • Protocol Number:
      012502

    • Principal Investigator:
      Mansi R Shah

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      ABBV-383 Etentamig Iberdomide

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Eastern Cooperative Oncology Group (ECOG) performance of 0 to 1.
    • Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
    • All participants must have measurable diseases per central laboratory as outlined in protocol

    Exclusion Criteria:

    • Has received prior etentamig treatment.
    • Prior exposure to BCMA-targeted therapy as noted in the protocol.
    • Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).

    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.

  • A Phase 2, Open-Label, Multicenter Study of BMS-986393, a GPRC5D-directed CAR T Cell Therapy in Adult Participants with Relapsed or Refractory Multiple Myeloma. - NCT06297226

    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.

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    • Protocol Number:
      012402

    • Principal Investigator:
      Mansi R Shah

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      A Arlocabtagene Autoleucel (BMS-986393)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

    • Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
    • Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT).
    • Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
    • Participants must have measurable disease during screening.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    Exclusion Criteria

    • Active or history of central nervous system involvement with MM.
    • Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded.
    • Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.
    • 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.

  • 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

    • Principal Investigator:
      Yun Kyoung Tiger

    • Phase:
      N/A

    • Scope:
      Local

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

    • Rutgers Cancer Institute
  • 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: 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)

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    • Protocol Number:
      012310

    • Principal Investigator:
      Mansi R Shah

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Linvoseltamab (REGN5458)

    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.

  • 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 R Shah

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Multiple Myeloma

    • Rutgers Cancer Institute
  • 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 R Shah

    • Phase:
      Phase II

    • Scope:
      Local

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

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

    • Drugs Involved:
      Loratadine/Placebo Pegfilgrastim

    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.

    • Robert Wood Johnson University Hospital
    • Rutgers Cancer Institute