Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT
18 Years and older, Male and Female
MyCheckpoint (MMRC-089) (primary)
MMRC-089 Anti LAG3/Anti TIGIT
This a Phase I/II randomized trial for patients with relapsed refractory Multiple Myeloma who
have relapsed after treatment with prior therapies. The protocol is designed to evaluate two
agents, Anti-LAG-3 and Anti-TIGIT, in order to understand their immunologic effects and
safety both as single agents and in combination with pomalidomide and dexamethasone. In these
arms, patients will be treated with either Anti-LAG-3 or Anti-TIGIT respectively for one
cycle as single agent followed by the addition of pomalidomide and dexamethasone in
combination for subsequent cycles.
A third arm allows patients to be treated with the FDA approved combination of elotuzumab
plus pomalidomide and dexamethsone as a control. This arm will thus allow a concurrent
standard of care comparator for the experimental arms.
This study will enroll 104 patients to one of three treatment arms. The study is open to
patients relapsing with refractory Multiple Myeloma who have:
- received 3 prior lines of therapy
- exposed to each of these 3 drug classes:
- proteasome inhibitors, and
- anti-CD38 monoclonal antibody
- relapsed and refractory are defined using the IMWG criteria:
- disease that is non-responsive while on salvage therapy or progresses within 60
days of last therapy in patients who have achieved minimal response or better at
some point previously to then progressing in their disease course.
- 18 years of age or greater.
- Willing and able to provide informed consent
- Patient has received at least 3 prior lines of therapy and must have received prior therapy including at least one drug from each drug class; IMiD, proteasome inhibitors, and anti-CD38 monoclonal antibody.
- The following laboratory values obtained = 14 days prior to initiation of therapy:
- ANC = 1000/ul (without growth factor support within 14 days of initiation of therapy)
- Hgb = 8 g/dl
- PLT = 75,000/ul (without transfusion support within 14 days of initiation of therapy)
- Total bilirubin <1.5 x upper limit of normal (ULN) or if total bilirubin is =1.5 x ULN, the direct bilirubin must be = 2.0 mg/dL (patients with Gilberts syndrome may have total bilirubin =3.0 x ULN
- AST and ALT < 2.5x ULN
- Creatinine Clearance = 30 mL/min by Cockcroft Gault Equation
- Measurable disease of MM as defined by at least ONE of the following:
- Serum monoclonal protein =1.0 g by protein electrophoresis
- =200 mg of monoclonal protein in the urine on 24-hour electrophoresis
- Serum immunoglobulin FLC =10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio.
- Normal thyroid function, or stable on hormone supplementation per investigator assessment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2.
- Willingness to return to enrolling institution for follow-up.
- Disease free of prior malignancies for = 3 year with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "insitu" of the cervix or breast, or prostate cancer not requiring therapy
- Ability to understand the purpose and risks of the study and provide signed and dated ICF and authorization to use protected health information.
- All study participants must be willing to be registered into, and comply with, the mandatory pomalidomide (POMALYST®) Risk Evaluation and Mitigation Strategy (REMS®) program and be willing to use contraception 28 days prior to pomalidomide treatment and continue until 120 days after the last dose of pomalidomide.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. For patient's intolerant to aspirin or for high-risk patients with prior history of thromboembolic events, thromboprophylaxis with other anti-coagulants agents, including low molecular weight heparin, warfarin, or novel oral anticoagulants such as apixaban or rivaroxaban, is allowed.
- All females of child bearing potential (FCBP)* must have a negative pregnancy test (urine or serum) documented =7 days prior to start of therapy with repeat pregnancy test on Day 1 of each cycle and at the EoT visit. Note: Additional pregnancy testing is required as a condition of the POMALYST REMS® program prior to and while on treatment and following the last dose of pomalidomide. FCBP must have 2 negative pregnancy tests prior to initiating pomalidomide treatment. The first test should be performed within 10-14 days prior to prescribing POMALYST and the second test within 24 hours prior to prescribing POMALYST therapy and then weekly during the first 4 weeks, then every 4 weeks thereafter in females with regular menstrual cycles, or every 2 weeks in females with irregular menstrual cycles. Protocol section 8.1 provides guidelines on the use and required time frames of contraception. NOTE: *A female of childbearing potential (FCBP) is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Treatment Sites in Georgia
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