A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma

Number of participants who experienced at least one adverse event. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition should be considered an AE.

Time frame: From first dose to 90 days after last dose (up to approximately 58 months)

Population: All participants who received at least 1 dose of the study medications.

Number of participants who experienced at least one serious adverse event. An SAE is any AE occurring at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, constitutes an important medical event.

Time frame: From first dose to 90 days after last dose (up to approximately 58 months)

Population: All participants who received at least 1 dose of the study medications.

Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. ORR was calculated as the percent of responders (multiplied by 100). Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to \< 200 mg per 24 hours.

Time frame: From first dose to up to approximately 66 months

Population: All enrolled participants who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment.

Pharmacokinetics of Durvalumab derived from serum concentration versus time data.

Time frame: Cycle 1 - Days 2, 8, 15, 22

Population: All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. \[AUC(TAU)\] was a pre-specified secondary outcome measure in the Simon Stage 1: D2 arm only.

Pharmacokinetics of Durvalumab derived from serum concentration versus time data.

Time frame: Cycle 1 - Days 2, 8, 15, 22

Population: All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. \[AUC(0-Last)\] was a pre-specified secondary outcome measure in the Simon Stage 1: D2 arm only.

Duration of response was calculated as the time from the earliest date of documented response (PR or better) to the earliest date of disease progression as determined by the investigator. For those participants where POM + DEX was added, duration of response was calculated as the time from the earliest date of documented response after POM + DEX was added (PR or better) to the earliest date of disease progression as determined by the investigator. Participants who are alive or lost to follow-up will be censored on the last-known-to-be-alive date. Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to \< 200 mg per 24 hours.

Time frame: From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months)

Population: All enrolled participants with a partial response or better, who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment. Pre-specified for data to be collected only in the PD3 arm.

Duration of response was calculated as the time from the earliest date of documented response (PR or better) to the earliest date of disease progression as determined by the investigator. For those participants where POM + DEX was added, duration of response was calculated as the time from the earliest date of documented response after POM + DEX was added (PR or better) to the earliest date of disease. Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to \< 200 mg per 24 hours. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h).

Time frame: From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months)

Population: All enrolled participants with a partial response or better, who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment. Pre-specified for data to be collected only in D2 and D2 + Pomalidomide + Dexamethasone arms.

Progression-free survival was calculated as the time between the enrollment to the first documentation of progressive disease or death from any cause during study, whichever occurs earlier using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h).

Time frame: From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months)

Population: All participants who received at least 1 dose of the study medications. Pre-specified for data to be collected only in the PD3 arm.

Progression-free survival was calculated as the time between the enrollment to the first documentation of progressive disease or death from any cause during study, whichever occurs earlier using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h).

Time frame: From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months)

Population: All participants who received at least 1 dose of the study medications. Pre-specified for data to be collected only in D2 and D2 + Pomalidomide + Dexamethasone arms.

Pharmacokinetics of Durvalumab derived from serum concentration versus time data.

Time frame: Cycle 1 - Days 2, 8, 15, 22

Population: All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. Cmax was a pre-specified secondary outcome measure in the Simon Stage 1: D2 arm only.

Pharmacokinetics of Durvalumab derived from serum concentration versus time data.

Time frame: Cycle 1 - Days 2, 8, 15, 22

Population: All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. Tmax was a pre-specified secondary outcome measure in the Simon Stage 1: D2 arm only.

Time-to-response is calculated as the time from enrollment to the first date of documented response (partial response or better). Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to \< 200 mg per 24 hours. For those participants where POM + DEX were added, time-to-response was calculated from the date POM and DEX were added to the first date of documented response (PR or better).

Time frame: From enrollment to earliest documented response (up to approximately 66 months)

Population: All enrolled participants who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment in the D2, D2 + Pomalidomide + Dexamethasone, and PD3 arms.