Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.

Time frame: Up to 3 years

Population: All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1.

ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than eqaul to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.

Time frame: Up to 3 years

Population: Intent-to-Treat (ITT) population analysis set included all enrolled participants who signed the informed consent during Phase 2.

Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.

Time frame: Up to 5 years

Population: Responders in all treated population analysis set included. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.

Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria (2011).

Time frame: Up to 5 years

Population: Responders in Intent-to-Treat (ITT) population analysis set included. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.

Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan Meier method.

Time frame: Up to 5 years

Population: ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.

Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.

Time frame: Up to 5 years

Population: ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.

TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria 2011): increase of \>=25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 g/dL) Urine M-component and/or (the absolute increase must be \>=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be \>10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be \>=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.

Time frame: Up to 5 years

Population: ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.

Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.

Time frame: Up to 5 years

Population: ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.