Trial Outcomes & Findings for A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma (NCT NCT02807454)

Last Updated: 2023-02-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

From first dose to up to approximately 66 months

Results posted on

2023-02-21

Participant Flow

Participants were randomized in a 1:1 ratio to receive either Durvalumab + Daratumumab (D2) or Durvalumab + Daratumumab + Pomalidomide + Dexamethasone (PD3). 32 participants were treated in the Simon Stage 1: D2 arm. No participants enrolled in the Simon Stage 2: D2 arm. 5 participants treated in the PD3 arm.

Participant milestones

Participant milestones
Measure	Simon Stage 1: D2 Arm Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Overall Study STARTED	32	5
Overall Study Participants in the D2 Arm Who Also Received Pomalidomide + Dexamethasone	7	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	32	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Simon Stage 1: D2 Arm Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Progressive Disease	30	3
Overall Study Other Reasons	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simon Stage 1: D2 Arm n=32 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm n=5 Participants Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	Total n=37 Participants Total of all reporting groups
Age, Continuous	63.2 Years STANDARD_DEVIATION 7.58 • n=5 Participants	63 Years STANDARD_DEVIATION 5.66 • n=7 Participants	63.2 Years STANDARD_DEVIATION 7.29 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	1 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	4 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	5 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	31 Participants n=5 Participants	5 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=32 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm n=4 Participants Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Overall Response Rate (ORR)	53.1 Percentage of participants	75.0 Percentage of participants	—

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=32 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm n=5 Participants Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Number of Participants With Adverse Events (AEs)	31 Participants	5 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=32 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm n=5 Participants Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Number of Participants With Serious Adverse Events (SAEs)	17 Participants	2 Participants	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=32 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm n=7 Participants Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm n=4 Participants Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Time-To-Response (TTR)	4.29 Weeks Interval 4.0 to 12.0	5.07 Weeks Interval 4.1 to 8.1	8.14 Weeks Interval 4.3 to 8.3

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=32 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm n=7 Participants Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Kaplan-Meier Estimate of Duration of Response (DOR) - Simon Stage 1: D2 Arm	8.31 Months Interval 3.7 to 11.1	8.41 Months Interval 3.7 to 12.0	—

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=4 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Kaplan-Meier Estimate of Duration of Response (DOR) - PD3 Arm	7.62 Months Interval 6.7 to 17.5	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=32 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm n=7 Participants Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Kaplan-Meier Estimate of Progression-Free Survival (PFS) - Simon Stage 1: D2 Arm	5.74 Months Interval 2.0 to 6.5	8.05 Months Interval 3.7 to 12.9	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=5 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Kaplan-Meier Estimate of Progression-Free Survival (PFS) - PD3 Arm	9.02 Months Interval 6.9 to 18.5	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=30 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Maximum Observed Plasma Concentration (Cmax) - Simon Stage 1: D2 Arm	315.806 ug/mL Geometric Coefficient of Variation 34.832	—	—

SECONDARY outcome

Timeframe: 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.

Pharmacokinetics of Durvalumab derived from serum concentration versus time data.

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=30 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Time of Maximum Observed Concentration (Tmax) - Simon Stage 1: D2 Arm	1.150 Hour Interval 1.03 to 1.83	—	—

SECONDARY outcome

Timeframe: 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.

Pharmacokinetics of Durvalumab derived from serum concentration versus time data.

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=30 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Area Under the Plasma Concentration-Time Curve to the Last Measurable Plasma Concentration [AUC(0-Last)] - Simon Stage 1: D2 Arm	77831.751 Hour*ug/mL Geometric Coefficient of Variation 48.535	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Simon Stage 1: D2 Arm n=28 Participants Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles	PD3 Arm Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Simon Stage 1: D2 Arm	83966.099 Hour*ug/mL Geometric Coefficient of Variation 46.115	—	—

Adverse Events

Simon Stage 1: D2 Arm

Serious events: 17 serious events

Other events: 31 other events

Deaths: 11 deaths

PD3 Arm

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email:

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Simon Stage 1: D2 Arm n=32 participants at risk Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.	PD3 Arm n=5 participants at risk Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
Blood and lymphatic system disorders Febrile neutropenia	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	20.0% 1/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Gastrointestinal disorders Diarrhoea	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
General disorders Death	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
General disorders Fatigue	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
General disorders General physical health deterioration	9.4% 3/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
General disorders Oedema peripheral	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
General disorders Pyrexia	6.2% 2/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Hepatobiliary disorders Hepatitis	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Cellulitis streptococcal	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Corynebacterium infection	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Influenza	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Neutropenic sepsis	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Pneumocystis jirovecii pneumonia	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Pneumonia	21.9% 7/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	20.0% 1/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Pneumonia respiratory syncytial viral	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Respiratory syncytial virus infection	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Sepsis	0.00% 0/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	40.0% 2/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Skin infection	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Upper respiratory tract infection	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Infections and infestations Vascular device infection	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Investigations Blood creatinine increased	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Investigations Weight decreased	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Metabolism and nutrition disorders Hyponatraemia	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Metabolism and nutrition disorders Tumour lysis syndrome	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Musculoskeletal and connective tissue disorders Back pain	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Renal and urinary disorders Acute kidney injury	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Renal and urinary disorders Nephrolithiasis	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.1% 1/32 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).	0.00% 0/5 • All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).