Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma.

Inclusion Criteria:

• Criteria 1 Relapsed or progressive multiple myeloma after last treatment

• Criteria 2 Males or females ≥ 18 years of age

• Criteria 3 Measurable disease with at least 1 of the following assessed within 21days prior to randomization:

• IgG multiple myeloma: serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL,

• IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL,

• urine M-protein ≥ 200 mg/24 hours,

• in subjects without measurable serum or urine M- protein, serum free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio

• Criteria 4 Received at least 1 but not more than 3 prior lines of therapy formultiple myeloma (induction therapy followed by stem cell transplant andconsolidation/maintenance therapy will be considered as 1 line of therapy

• Criteria 5 Prior therapy with carfilzomib is allowed as long as the patient had atleast a partial response (PR) to most recent therapy with carfilzomib, was notremoved due to toxicity, did not relapse within 60 days from discontinuation ofcarfilzomib, and will have at least a 6-month carfilzomib treatment-free intervalfrom last dose received until first study treatment. (Patients may receivemaintenance therapy with drugs that are not proteasome inhibitors or CD38 antibodiesduring this 6-month carfilzomib treatment free interval)

• Criteria 6 Prior therapy with anti-CD38 antibodies is allowed as long as the patienthad at least a PR to most recent therapy with CD38 antibody, was not removed due totoxicity, did not relapse within 60 days from intensive treatment (at least everyother week) of CD38 antibody therapy, and will have at least a 6 month CD38 antibodytreatment-free interval from last dose received until first study treatment

• Other inclusion criteria may apply

Exclusion Criteria:

• Criteria 1 Waldenström macroglobulinemia

• Criteria 2 Multiple myeloma of IgM subtype

• Criteria 3 POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonalprotein, and skin changes)

• Criteria 4 Plasma cell leukemia (> 2.0 * 10^9/L circulating plasma cells by standarddifferential)

• Criteria 5 Myelodysplastic syndrome

• Criteria 6 Known moderate or severe persistent asthma within the past 2 years

• Criteria 7 Known chronic obstructive pulmonary disease (COPD) with a FEV1 < 50% ofpredicted normal

• Criteria 8 Active congestive heart failure (New York Heart Association [NYHA] ClassIII to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significantelectrocardiogram (ECG) abnormalities, screening ECG with corrected QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction within 4 monthsprior to randomization

• Other exclusion criteria may apply