By accessing or using the AdisInsight platform you agree to the terms of use. Taken together, these results strongly support AMG 701-based clinical studies, both as monotherapy (NCT03287908) and in combination with IMiDs to enhance elimination of residual diseases and prolong long-term durable responses in MM. If you opt-out your email will still be collected for registration purposes. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2. Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Major surgery within 28 days prior to study day 1. Subjects likely to not be available to complete all protocol-required study visits or procedures including BM aspirates/biopsies, and/or to comply with all required study procedures to the best of the subject and investigator’s knowledge. Current or known history of autoimmune diseases requiring systemic treatment in past 5 years. In addition, females of childbearing potential unwilling to undergo pregnancy testing weekly during the first 4 weeks of pomalidomide use followed by pregnancy testing every 4 weeks in females with regular menses or every 2 weeks in females with irregular menstrual cycles. Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases. Age ≥ 18 years at the time of signing the informed consent. You have the right to opt-out of sharing your email address with your organization but doing so may negatively affect your organization’s decision to renew their subscription to AdisInsight. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. We'll send you alerts when this treatment is updated. Most importantly, while AMG 701 or len group showed tumor progress eventually, the combination of AMG 701 with len continuously suppressed tumor growth (p<0.05 after d26; p<0.001 after d40 for combination vs either agent alone). Final gross price and currency may vary according to local VAT and billing address. Final gross price and currency may vary according to local VAT and billing address. Your email address will not be shared without your permission. Detectable hepatitis B virus DNA suggests occult hepatitis B; Positive Hepatitis C virus antibody (HepCAb): hepatitis C virus RNA by PCR is necessary. In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. © 1998-2020 Mayo Foundation for Medical Education and Research (MFMER). In the human NCI-H929 xenograft model reconstituted with human T effector cells, AMG 701 effectively blocked tumor growth 5d after the first injection, regardless of doses (0.02-2 mg/kg). Time-course immunophenotyping studies showed that AMG 701 transiently upregulated the expression of key immune checkpoint and costimulatory markers on both CD4 and CD8 T cells. Last anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks prior to study day 1. Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase Subjects must have responded to at least 1 prior line with at least a PR. Combined treatments induce a more pronounced immunomodulation than AMG 701 alone in the presence of OCs, as evidenced by higher percentage of CM+EM and CD8/CD4 ratio at d8. AMG 701 rapidly upregulated cell surface expression of CD107a and the production of IFNγ and TNFα, more so in CD8 than CD4 T subsets. The induced T cells purified from ex vivo co-cultures still effectively lysed MM cells with lower BCMA levels. Use the arrow keys Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best. Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase. Mice receiving MM cells were treated, from d15 until the end of the study, with len once daily, AMG 701 once weekly, or combination of AMG 701 and len. The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy. There is no end date for eligibility to submit a data sharing request for this study. A link to download a PDF version of the drug profile will be included in your email receipt. Subject has provided informed consent prior to initiation of any study-specific activities/procedures. Cancer Center Clinical Trials Referral Office. does not have a subscription It stimulated the proliferation and activation of T cells, to a greater extent in CD8 vs CD4 T cells, leading to significantly increased ratios of CD8/CD4 T cells. Please refer to our, Antibody-dependent cell cytotoxicity; Cytotoxic T lymphocyte stimulants, Phase-I clinical trials in Multiple myeloma (Second-line therapy or greater) in Australia (IV) (NCT03287908), Phase-I clinical trials in Multiple myeloma (Second-line therapy or greater) in USA (IV) (NCT03287908), Amgen plans a phase I trial in Multiple myeloma in October 2017 (NCT03287908). Females planning to become pregnant while on study through 75 days after receiving the last dose of AMG 701 or 28 days after the last dose pomalidomide or dexamethasone, whichever occurs later. Mayo Clinic College of Medicine and Science, Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education, Advertising and sponsorship opportunities. Prior treatment with any drug or construct that targets BCMA on tumor cells (eg, other bispecific antibody constructs, antibody drug conjugates, or CAR-T cells), other than Group C where prior treatment with GSK2857916 (belantamab mafodotin) is required. Privacy Policy, Disclaimer, General Terms & Conditions. Detectable hepatitis C virus RNA suggests chronic hepatitis C. Positive results for human immunodeficiency virus (HIV). Information provided by (Responsible Party): The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in adult subjects with relapsed/refractory multiple myeloma (RRMM). Autologous stem cell transplantation less than 90 days prior to study day 1. Multiple myeloma meeting the following criteria: Pathologically-documented diagnosis of multiple myeloma that is relapsed or is refractory as defined by the following: Inclusion criteria specific to AMG 701-P±d include: Exclusion criteria specific to AMG 701-P±d include: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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