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Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

RecruitingPhase 2Ages 18 Years - anyAllSCRI Development Innovations, LLC
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In plain words

What the trial is, and whether it could suit you

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Be ≥18 years of age (or the higher legal age in the jurisdiction in which the study is taking place) at the time of informed consent * Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011). * Teclistamab or Talquetamab + Tocilizumab: has received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody. * Teclistamab + Oral Dexamethasone: has received 1 or more prior MM therapies including a PI, IMiD and/or CD38 antibody. * Teclistamab or Talquetamab + Tocilizumab: has an ECOG performance status (Oken 1982) of 0 to 1. Teclistamab + Oral Dexamethasone: has an ECOG performance status (Oken 1982) of 0 to 2. * Measurable disease at screening, as assessed by local laboratory, defined by any of the following: * Serum M-protein level ≥0.5 g/dL; or * Urine M-protein level ≥200 mg/24 hours; or * Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio. * For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm). * Human immunodeficiency virus-positive participants are eligible if they meet all of the following: * No detectable viral load (i.e., \<50 copies/mL) at screening * CD4+ count \>300 cells/mm3 at screening * No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening * Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance/progression should occur at least 3 months prior to enrollment. A change in HAART due to toxicity is allowed up to 4 weeks prior to enrollment. * Adequate organ system function * Body weight \>35 kg. * A participant of childbearing potential must have a negative highly sensitive serum (β-hCG) at screening and within 72 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study. * A participant must agree to abide by protocol defined contraceptive requirements for the duration of the study including avoiding donating gametes for specified period of time. * A participant must sign an ICF indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. * A participant is required to stay within 60 minutes of transportation to the site and remain in the company of a competent adult at all times until 48 hours following administration of all doses within the teclistamab step-up dosing schedules * A participant is required to stay within 30 minutes of transportation to the site and remain in the company of a competent adult at all times until 48 hours following administration of all doses within the talquetamab step-up dosing schedule * A participant must agree to carry the study participant identification wallet card at all times. * A participant must comply with all the protocol requirement procedures, including measuring and recording of body temperature and blood oxygen saturation twice daily (≥8 hours apart) during the first 2 cycles of teclistamab or talquetamab treatment and coming to the study site for safety assessments. * A participant and the accompanying competent adult must be made aware of the presenting sign sand symptoms of teclistamab- or talquetamab- associated toxicities, including but not limited to CRS, ICANS, infections, etc. The accompanying competent adult must watch the participant at all times for teclistamab- or talquetamab- associated toxicities, until 48 hours after the first treatment dose of teclistamab or talquetamab. Exclusion Criteria: * Has a rapidly progressing disease per investigator assessment. * Has plasma cell leukemia (\>2.0×10\^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis. * Has known active CNS involvement or exhibits clinical signs of meningeal involvement of MM. * Has risk factors for developing clinically significant TLS and requiring management with increased hydration, allopurinol, or rasburicase. * Has myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are: * Any malignancy that was not progressing nor requiring treatment change in the last 12 months. * Malignancies treated within the last 12 months and considered at very low risk for recurrence: * Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \<3 cm, no CIS). * Skin cancer (non-melanoma or melanoma). * Noninvasive cervical cancer. * Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents. * Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment). * Other malignancy that is considered at minimal risk of recurrence. * Has Grade ≥3 hematologic AEs or Grade ≥3, clinically significant non-hematologic AEs. * Has fever or active infection (bacterial, viral, or uncontrolled systemic fungal) at time of study enrollment. * Has active autoimmune disease or a documented history of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing. * Has clinically significant coagulopathy that would increase the risk of bleeding in the setting of cytopenia. * Shows a deterioration in neurologic status, including mental status changes such as confusion or increased somnolence. * Has psychiatric disorders (eg, alcohol or drug abuse), dementia, or altered mental status that would compromise the ability to provide informed consent or comply with the clinica
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What it tests

  • Teclistamab
  • Talquetamab
  • Tocilizumab
  • Oral Dexamethasone
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Where

17 sites
Arizona Oncology Associates
Tucson, United States
Colorado Blood Cancer Institute
Denver, United States
Rocky Mountain Cancer Center
Denver, United States
Medical Oncology Hematology Consultants
Newark, United States
Florida Cancer Specialists
Lake Mary, United States
Maryland Oncology Hematology
Columbia, United States
Minnesota Oncology Hematology
Minneapolis, United States
Virginia Oncology Associates
Elizabeth City, United States

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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