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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT04119336
Recruitment Status Recruiting
First Posted October 8, 2019
Last update posted February 28, 2020
This research is being done to assess the effectiveness and safety of the combination of nivolumab with ixazomib, cyclophosphamide, and dexamethasone in relapsed and refractory multiple myeloma.
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. - The U.S. Food and Drug Administration (FDA) has not approved nivolumab for relapsed and refractory Multiple Myeloma but it has been approved for other uses. - The FDA has approved ixazomib and cyclophosphamide as treatment options for your disease. - Nivolumab is a type of antibody (a protein that attaches to other cells to fight off infection and disease) that attaches to and inhibits a protein called PD-1. -- PD-1 is a checkpoint protein on immune cells called T cells. It normally acts as a type of "off switch" that helps keep the T cells from attacking other cells in the body. Some cancer cells have large amounts of PD-L1 which binds to PD-1 and turns off the immune system. Nivolumab inhibits PD-1 and helps take the "brake" off the immune system. The investigators' hope that nivolumab will inhibit the PD-1 protein, thus allowing your immune cells to recognize and destroy cancer cells. - Ixazomib is a type of inhibitor that blocks a protein in your cells called a proteasome. This protein is responsible for breaking down other proteins in your cells when they need to be disposed of. By blocking the proteasome from working, a buildup of proteins will be created in the cancer cells, which may lead to cell death. - The investigators hope that the combination of ixazomib and nivolumab with standard of care chemotherapy cyclophosphamide and dexamethasone will work together with ixazomib and nivolumab to treat multiple myeloma.
|Experimental: Nivolumab and Ixazomib
- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. Oral: Ixazomib given weekly on days 1, 8, 15 Dexamethasone given weekly during cycle Infused: Nivolumab given once per cycle Cyclophosphamide given on days 1, 8, 15 during cycle
Given intravenously once per cycle
Given orally on days 1, 8, 15.
Given orally on days 1, 8, 15, 22
Given intravenously on days 1, 8, 15.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Previously treated relapsed and refractory multiple myeloma per International Myeloma
Working Group consensus criteria (Rajkumar et al., 2011).
- Patients must have received at least three prior lines of therapy, including an
immunomodulatory drug (e.g. lenalidomide, pomalidomide), a proteasome inhibitor (e.g.
bortezomib, carfilzomib), and anti-CD38 monoclonal antibody (e.g. daratumumab)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
- Age ≥ 18 years
- All laboratory assessments for eligibility should be performed within 21 days of
initiation of protocol therapy unless otherwise specified.
- Measurable disease of multiple myeloma as defined by at least one of the following
(IgD and IgA with monoclonal protein < 0.5 g/dL may be permitted after discussion with PI): - Serum monoclonal protein ≥ 0.5 g/dL (or quantitative IgA ≥ 1000 mg/dL), or - ≥ 200 mg of monoclonal protein in the urine on 24-hour urine protein electrophoresis, and/or - Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio - ANC ≥ 1000/μL. G-CSF is not permitted within 14 days of screening. - Platelet count ≥ 75,000/µL. Platelet transfusions are not permitted within 7 days of screening. - Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria. - Calculated creatinine clearance of ≥ 30 mL/min according to Cockroft-Gault equation. - Adequate hepatic function, as evidenced by each of the following: - Serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values < 3 × the institutional upper limit of normal (ULN). - Serum bilirubin values 2 medications for adequate control; diabetes mellitus with >
2 episodes of ketoacidosis in the preceding 12 months; or chronic obstructive
pulmonary disease (COPD) requiring > 2 hospitalizations in the preceding 12 months.
3.2.15 Autoimmune disease: patients with a history of inflammatory bowel disease, including
ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with
a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive
sclerosis [scleroderma], systemic lupus erythematosus, autoimmune pneumonitis, autoimmune
vasculitis (e.g., Wegener's granulomatosis) and motor neuropathy considered of autoimmune
origin (e.g. Guillain-Barré syndrome and myasthenia gravis). Patients with vitiligo, type I
diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring
hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected
to recur in the absence of an external trigger are permitted to enroll.
- Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary
- Major surgery within 14 days prior to study registration.
- Central nervous system involvement.
- Infection requiring systemic antibiotic therapy or other serious infection within 14
days prior to study registration
- Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin,
carbamazepine, phenytoin, phenobarbital), or use of St. John's wort within 14 days
prior to C1D1.
- Receipt of a live or attenuated vaccine within 30 days of C1D1.
- Any serious medical of psychiatric illness that could, in the investigator's opinion,
potentially interfere with the completion of treatment according to this protocol.
- Known allergy to any study medications, their analogs, or excipients in the various
formulations of any agent.
Contact: Andrew Yee, MD (617) 726-2000 email@example.com
United States, Massachusetts
Massachusetts General Hospital Cancer Center
United States, Massachusetts
Mass General/North Shore Cancer Center
United States, Massachusetts
Massachusett General Hopsital at Newton Wellsley Hospital
Andrew Yee, MD
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Andrew Yee, MD Massachusetts General Hospital