An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

Best Overall Response

the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response

Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

Best Overall Response - Multiple Myeloma Group

the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.

Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

Duration of Response

the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Remission and Partial Remission

Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to approximately 37 months Nivo Liri: approximately up to 4 years 1 month

Duration of Response - Multiple Myeloma Group

the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response

Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

Progression Free Survival

Progression free survival (PFS) is defined as the time between date of randomization and date of progression or death, whichever occurs first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not progress or die were censored on the date of their last efficacy assessment.

Time frame: From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)

Progression Free Survival Rate

The percentage of participants remaining progression free at the specified timepoints (up to 48 Months)

Time frame: From randomization to the specified timepoints (up to 48 months)

Overall Survival

The percentage of participants remaining alive. Median values are computed using Kaplan-Meier method

Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to3 years Nivo Liri: approximately up to 4 years 1 month

Number of Participants With PD-L1 Expression

Number of Participants with PD-L1 expression in the following categories * baseline PD-L1 expression ≥ 1% * baseline PD-L1 expression \< 1% * without PD-L1 quantifiable at baseline

Time frame: At baseline (prior to start of study treatment)

Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score

mSWAT is a scoring technique involving the direct assessment of the percentage of body-surface-area (BSA) affected by skin lesions. There are 12 body regions (each one assigned a different percentage of BSA). For each body region, the assigned BSA percentage is multiplied by a factor weighing the type and severity of lesion observed (patch= x1, plaque = x2, tumor= x4). The sum of the individual body region sub-scores is then summed to generate the final mSWAT score, which ranges from 0 (best outcome) to 400 (worst outcome).

Time frame: From baseline (last measurement before start of study treatment) to last available measurement after start of study treatment (88 weeks for Nivo mono, 93 weeks for nivo+ipi, 25 weeks for nivo+liri)

Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort

Time to MRD Negativity status in specific NGS and NGF sensitivity levels

Time frame: approximately up to 4 years

Objective Response Rate in the Nivolumab + Daratumumab Cohort

Time frame: approximately up to 4 years

Duration of Response in the Nivolumab + Daratumumab Cohort

Time frame: approximately up to 4 years

Progression Free Survival in the Nivolumab + Daratumumab Cohort

Time frame: approximately up to 4 years

Cmax in the Nivolumab + Daratumumab Cohort

Maximum observed serum concentration

Time frame: approximately up to 4 years

Tmax in the Nivolumab + Daratumumab Cohort

Time of maximum observed serum concentration

Time frame: approximately up to 4 years

Cmin in the Nivolumab + Daratumumab Cohort

Serum concentration achieved at the end of dosing interval (trough concentration)

Time frame: approximately up to 4 years

AUC (0-T) in the Nivolumab + Daratumumab Cohort

Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration

Time frame: approximately up to 4 years

AUC (TAU) in the Nivolumab + Daratumumab Cohort

Area under the concentration-time curve in one dosing interval

Time frame: approximately up to 4 years

End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort

Serum concentration achieved at the end of study drug infusion

Time frame: Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days