Relapsed Refractory Multiple Myeloma (RRMM) Clinical Trials

• Must be able to understand and voluntarily sign an informed consent form (ICF).

• Must be ≥ 18 years of age at the time of signing the ICF

• Must be able to adhere to the study visit schedule and other protocol requirements.

• Relapsed and/or refractory MM with:

• Documented evidence of progressive disease (PD) after achieving at least stable disease (SD) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM). OR Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM).

• Previously undergone treatment with at least one immunomodulatory drug (lenalidomide or pomalidomide), one proteasome inhibitor (bortezomib, ixazomib, carfilzomib) and one anti-CD38 drug (daratumumab or isatuximab). These drugs could have been used in separate regimens or in combination.

• No effective standard of care options available

• Patients with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met:

• transplant was \> 12 weeks prior to study enrolment

• no active infection

• Patients with measurable disease defined as at least one of the following (these baseline laboratory studies for determining eligibility must be obtained within 28 days prior to start of study drug):

• Serum M-protein ≥ 0.5 g/dl (≥ 5 g/l)

• Urine M-protein ≥ 200 mg/24 h

• Serum free light chains (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) and an abnormal serum free light chain ratio (\< 0.26 or \> 1.65)

• If the serum protein electrophoresis is unreliable for routine M-protein measurement, quantitative immunoglobulin levels on nephelometry or turbidometry will be followed.

• Must have Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

• Females of child-bearing potential (FCBP) must have a negative serum pregnancy test and must either commit to continued abstinence from heterosexual intercourse or must abide by birth control requirements as described.

• Men with a female partner of childbearing potential must agree to use effective contraception from the time of first dose of study until 90 days after the last dose of study treatment to allow for clearance of any altered sperm.

• Able to take oral medications

• All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5) must be ≤Grade 1 at the time of enrollment except for alopecia or be deemed to be irreversible (for example, steroid induced cataracts or peripheral neuropathy).

• The following laboratory results must be met within 7 days of first study drug administration:

• Absolute neutrophil count (ANC) \>1000 cells/dL (1.0 x 10\^9/L). Growth factors cannot be given within 7 days of study drug administration.

• Serum AST and ALT ≤ 3 x upper limit of normal (ULN).

• Creatinine clearance ≥ 20 mL/min either directly measured via 24-hour urine collection or calculated using Cockroft-Gault

• Platelet count ≥ 50 x 109/L. For patients with \> 50% myeloma involvement in the marrow, a platelet count of ≥30 x 109/L is allowed. Patients may not have received a platelet transfusion within 72 hours prior to the platelet count used for eligibility

• Hemoglobin ≥ 80 g/L. Patients may receive red blood cell (RBC) transfusions in accordance with institutional guidelines to meet this criterion. Patients may not have received a red blood cell (RBC) transfusion within 72 hours prior to the hemoglobin result used for eligibility; use of growth factors is allowed.

• Total bilirubin ≤ 1.5 x ULN, unless known to have Gilbert's disease.

• Albumin ≥ 2.0 g/dL (20 g/L).

• Calcium \<1.2xULN.