6 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.

    View All Details
    • 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 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma. - NCT04133636

    To evaluate the overall minimal residual disease (MRD) negative rate of subjects who receive JNJ-68284528.

    View All Details
    • Protocol Number:
      011909

    • Principal Investigator:
      Mansi R Shah

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Drugs Involved:
      JNJ-68284528

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines
    • Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than or equal to (<=) 12 months after treatment with autologous stem cell transplantation (ASCT) or <=12 months from the start of anti-myeloma therapy for participants who have not had an ASCT
    • Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy
    • Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation
    • Cohort E: Have newly diagnosed multiple myeloma without prior therapy (one cycle of prior therapy before enrollment is acceptable) and classified as high risk defined as either: 1) International Staging System (ISS) stage III criteria, Beta 2 microglobulin greater than or equal to (>=) 5.5 milligrams per liter (mg/L) (via local or central laboratory assessment) or 2) high risk cytogenetic features del(17/17p), t (14;16), t(14;20), 1q amplification (at least 4 total copies) in at least 20 percent (%) of the total plasma cell population
    • Cohort F:
    • Participant must have a documented efficacy response of very good partial response (VGPR) or better, without progressive disease prior to enrollment, as assessed per IMWG 2016 criteria
    • Received initial therapy as specified below. The dose/schedule of cycles administered will be as per standard of care. It is acceptable for up to 1 cycle of the protocol-specified regimens to be missing one of the listed agents (example, held due to toxicity). Acceptable combinations include: At least 5 to 8 cycles of initial therapy with daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd). The dose/schedule of cycles administered will be as per standard of care or; at least 4 to 8 cycles of initial therapy with daratumumab, lenalidomide and dexamethasone (D-Rd) or; at least 4 to 8 cycles of initial therapy with a carfilzomib-based triplet or quadruplet regimen
    • Cohort G: Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: a) Ineligibility due to advanced age; or b) Ineligibility due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or c) Subject refusal of high-dose chemotherapy with ASCT as initial treatment
    • Cohort H: Considered a candidate for high-dose chemotherapy with ASCT as initial treatment
    • Cohorts A, B, C, E, G, H:
    • Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligrams (mg)/24 hours
    • Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
    • Cohort A: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole -body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria. A minimum of one lesion with a bi-dimensional measurement of at least 1 centimeter (cm)*1 cm is required
    • Cohorts B, C: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria
    • Cohorts A, B, C, D, E, F, G, H: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

    Exclusion Criteria:

    • Cohorts A, B, D, F: Any therapy that is targeted to BCMA
    • Cohorts A, B, C, D, F: Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
    • Cohorts A, B, C, D, F:
    • Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
    • Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days (Cohort A, B, C, F) or 14 days (Cohort D) prior to apheresis
    • Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder
    • Cohorts A, B, C, D, E, F: Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
    • Cohorts F, G, and H: Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: a) non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured; b) skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured; c) non-invasive cervical cancer treated within the last 24 months that is considered completely cured; d) localized prostate cancer (N0M0): with a Gleason score of greater than or equal to (=>)6, treated within the last 24 months or untreated and under surveillance, with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence, or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence, e) breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence; f) malignancy that is considered cured with minimal risk of recurrence
    • Cohorts E, G, and H: Frailty index of >= 2 according to Myeloma Geriatric Assessment score

    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
  • 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.

    View All Details
    • 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)

    View All Details
    • 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.

    • Rutgers Cancer Institute
  • 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.

    View All Details
    • 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.

    View All Details
    • 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