Multiple Myeloma Clinical Trials

• Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)

• Measurable disease based on IMWG criteria as defined by at least 1 of the following:

‣ Serum M-protein ≥0.5 g/dL (Part 1) and ≥1 g/dL (Part 2);

⁃ Urinary M-protein excretion ≥200 mg/24 hours;

⁃ Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).

• Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age \<65 years with comorbidities impacting the possibility of transplant.

• Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:

‣ Participants not considered candidates for high-dose chemotherapy and ASCT due to age or

⁃ Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.

• ECOG performance status ≤2.

• Not pregnant and willing to use contraception

• For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.