Comparison of Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide and a Proteasome InhibitorDaratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14)

• ClinicalTrials.gov Identifier: NCT03180736
• Recruitment Status: Unknown
• First Posted: June 8, 2017
• Results First Posted: May 11, 2022
• Last Update Posted: May 11, 2022
• Sponsor: Stichting European Myeloma Network
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Stichting European Myeloma Network

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Multiple Myeloma
• Interventions: Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone
• Enrollment: 304

Participant Flow

Recruitment Details

Pre-assignment Details

Patients were randomly allocated to 1 of the 2 arms (Pd or DPd). 7 patients started with daratumumab IV. The study was amended to daratumumab SC formulation. Of those 7 patients, 4 switched to daratumumab SC and 3 discontinued treatment before the study was amended to SC administration. All other daratumumab-treated patients (142 of 149 DPd subjects) received only daratumumab SC. In summary, almost all patients (146 of 149) that were treated in the DPd arm received daratumumab SC.

Arm/Group Title	Daratumumab+Pomalidomide+Dexamethasone	Pomalidomide + Dexamethasone
Arm/Group Description	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
Period Title: Overall Study
Started	151	153
Treated	149	150
Completed	60	33
Not Completed	91	120
Reason Not Completed
Adverse Event	3	4
Death	10	7
Withdrawal by Subject	5	12
Lost to Follow-up	1	0
Lack of Efficacy	66	87
Physician Decision	4	7
randomized but not treated	2	3

Baseline Characteristics

Arm/Group Title		Daratumumab+Pomalidomide+Dexamethasone	Pomalidomide + Dexamethasone	Total
Arm/Group Description		Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles	Total of all reporting groups
Overall Number of Baseline Participants		151	153	304
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	151 participants	153 participants	304 participants
		65.4 (9.57)	66.5 (9.70)	66.0 (9.63)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	151 participants	153 participants	304 participants
	Female	72 47.7%	71 46.4%	143 47.0%
	Male	79 52.3%	82 53.6%	161 53.0%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Greece	Number Analyzed	151 participants	153 participants	304 participants
		53	44	97
Netherlands	Number Analyzed	151 participants	153 participants	304 participants
		5	4	9
Turkey	Number Analyzed	151 participants	153 participants	304 participants
		16	24	40
Belgium	Number Analyzed	151 participants	153 participants	304 participants
		7	9	16
Czechia	Number Analyzed	151 participants	153 participants	304 participants
		6	4	10
Denmark	Number Analyzed	151 participants	153 participants	304 participants
		1	1	2
Italy	Number Analyzed	151 participants	153 participants	304 participants
		19	20	39
Serbia	Number Analyzed	151 participants	153 participants	304 participants
		4	5	9
Germany	Number Analyzed	151 participants	153 participants	304 participants
		8	7	15
Spain	Number Analyzed	151 participants	153 participants	304 participants
		15	22	37
Poland	Number Analyzed	151 participants	153 participants	304 participants
		1	1	2
France	Number Analyzed	151 participants	153 participants	304 participants
		16	12	28
Stage of Disease (ISS) [1]; Measure Type: Count of Participants; Unit of measure: Participants
I	Number Analyzed	151 participants	153 participants	304 participants
		68 45.0%	69 45.1%	137 45.1%
II	Number Analyzed	151 participants	153 participants	304 participants
		50 33.1%	51 33.3%	101 33.2%
III	Number Analyzed	151 participants	153 participants	304 participants
		33 21.9%	33 21.6%	66 21.7%
		[1] Measure Description: The International Staging System (ISS) consists of the following 3 stages; Stage I: serum beta2-microglobulin less than (<) 3.5 milligram per liter (mg/L) and albumin greater than or equal to (≥) 3.5 gram per 100 Milliliter (g/100 mL); Stage II: neither stage I nor stage III; and Stage III: serum beta2-microglobulin greater than or equal to (≥) 5.5 mg/L. Higher stages indicate more severe disease (i.e. worse outcomes).
No. of Prior Lines of Therapy; Measure Type: Count of Participants; Unit of measure: Participants
1	Number Analyzed	151 participants	153 participants	304 participants
		16 10.6%	18 11.8%	34 11.2%
2-3	Number Analyzed	151 participants	153 participants	304 participants
		114 75.5%	113 73.9%	227 74.7%
≥4	Number Analyzed	151 participants	153 participants	304 participants
		21 13.9%	22 14.4%	43 14.1%

Outcome Measures

1. Primary Outcome

Title	Comparison of Progression Free Survival Between Treatment Arms
Description	Comparison of Progression Free Survival between treatment arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone)[ Time Frame: Assessed monthly from randomization until disease progression (PD) or death whichever occurs first (approximately up to 3 years)] Progression free survival is defined as the time, in months, from randomization to the date of the first documented PD or death due to any cause, whichever comes first. PD will be assessed by the investigator based on the analysis of serum and urine protein electrophoresis (sPEP and uPEP), serum and urine immunofixation (sIFE and uIFE), serum free light chain protein (sFLC),corrected serum calcium assessment, imaging and bone marrow assessments as per modified IMWG guidelines.
Time Frame	Assessed monthly from randomization until disease progression (PD) or death whichever occurs first (approximately up to 3 years)]

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.

Arm/Group Title	Daratumumab+Pomalidomide+Dexamethasone	Pomalidomide + Dexamethasone
Arm/Group Description:	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
Overall Number of Participants Analyzed	151	153
Median (95% Confidence Interval); Unit of Measure: months
	12.42; (8.34 to 19.32)	6.93; (5.52 to 9.26)

2. Secondary Outcome

Title	Overall Response Rate
Description	Overall response rate is defined as the percentage of randomized subjects who achieve a best response of PR or better using modified IMWG criteria as their best overall response
Time Frame	Assessed monthly from Randomization until PD, (approximately up to 3 years)]

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Daratumumab+Pomalidomide+Dexamethasone	Pomalidomide + Dexamethasone
Arm/Group Description:	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
Overall Number of Participants Analyzed	151	153
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	68.87; (60.84 to 76.15)	46.41; (38.32 to 54.64)

3. Secondary Outcome

Title	Depth of Response
Description	To assess the depth of response by analyzing the percentage of patients with Minimal Residual Disease (MRD) negativity (<10-5), considering the patients who have achieved CR or better, and patients with suspected CR/sCR.
Time Frame	From randomization to disease progression or subsequent antimyeloma therapy, assessed up to approximately 3 years.

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.

Arm/Group Title	Daratumumab+Pomalidomide+Dexamethasone	Pomalidomide + Dexamethasone
Arm/Group Description:	Daratumumab at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle Daratumumab: Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
Overall Number of Participants Analyzed	151	153
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	8.61; (4.66 to 14.27)	1.96; (0.41 to 5.62)

4. Secondary Outcome

Title	Duration of Response
Description	Duration of response will be restricted to the randomized subjects who achieve a best objective response of PR or better. It is measured from the time, in months, that the criteria for objective response are first met until the date of a progression event (according to the primary definition of PFS).
Time Frame	From informed consent until 30 days after last study treatment, assessed up to approximately 3 years.

Outcome Measure Data

Analysis Population Description

Percentages are computed on subjects in the intent-to-treat analysis set with a first response of partial response or better.

Arm/Group Title	Daratumumab+Pomalidomide+Dexamethasone	Pomalidomide + Dexamethasone
Arm/Group Description:	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
Overall Number of Participants Analyzed	104	71
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (15.21 to NA)	15.90; (8.31 to 24.80)

[1]

Median and upper limit of 95% CI was not estimable due to short follow-up by participants".

5. Secondary Outcome

Title	Time to Next Therapy
Description	Time to next therapy will be defined as the time, in months, from randomization to the date to next anti-neoplastic therapy or death from any cause, whichever comes first.
Time Frame	From randomization until the date to next anti-neoplastic therapy or death from any cause, whichever comes first (approximately up to 3 years)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.

Arm/Group Title	Daratumumab+Pomalidomide+Dexamethasone	Pomalidomide + Dexamethasone
Arm/Group Description:	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
Overall Number of Participants Analyzed	151	153
Median (95% Confidence Interval); Unit of Measure: months
	23.23 [1]; (13.80 to NA)	11.83; (8.87 to 15.38)

[1]

Upper limit of 95% CI was not estimable due to short follow-up by participants

6. Secondary Outcome

Title	Overall Survival
Description	Overall survival is defined as the time, in months, from randomization to the date of death from any cause.
Time Frame	From randomization until death from any cause (up to 5 years)

Outcome Measure Data Not Reported

7. Secondary Outcome

Title	Health-related Quality of Life-Time to Worsening in EORTC QLQ-C30 Scale Scores
Description	Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups.
Time Frame	Day 1 of each treatment cycle, at end of treatment, and every 4 weeks post treatment until PD (approximately up to 3 years)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.

Arm/Group Title	Daratumumab+Pomalidomide+Dexamethasone	Pomalidomide + Dexamethasone
Arm/Group Description:	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
Overall Number of Participants Analyzed	151	153
Median (95% Confidence Interval); Unit of Measure: months
	4.01; (2.20 to 7.59)	3.84; (3.02 to 5.91)

8. Secondary Outcome

Title	Health-related Quality of Life-Time to Worsening in EQ-5D-5L Utility Score
Description	Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups. The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"
Time Frame	Day 1 of each treatment cycle, at end of treatment, and every 4 weeks post treatment until PD (approximately up to 3 years)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.

Arm/Group Title	Daratumumab+Pomalidomide+Dexamethasone	Pomalidomide + Dexamethasone
Arm/Group Description:	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
Overall Number of Participants Analyzed	151	153
Mean (95% Confidence Interval); Unit of Measure: months
	7.39; (5.32 to 19.52)	6.14; (3.88 to 13.14)

9. Secondary Outcome

Title	Health-related Quality of Life-Time to Worsening in EQ-5D-5L Visual Analogue Scale
Description	Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups. The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"
Time Frame	Day 1 of each treatment cycle, at end of treatment, and every 4 weeks post treatment until PD (approximately up to 3 years)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.

Arm/Group Title	Daratumumab+Pomalidomide+Dexamethasone	Pomalidomide + Dexamethasone
Arm/Group Description:	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.	Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
Overall Number of Participants Analyzed	151	153
Mean (95% Confidence Interval); Unit of Measure: months
	3.78; (2.83 to 6.54)	2.86; (1.94 to 3.71)

Adverse Events

Time Frame	From informed consent until 30 days after last study treatment, assessed up to approximately 3 years.
Adverse Event Reporting Description	Almost all patients (146 of 149) in the DPd arm received daratumumab SC. 7 patients received daratumumab IV,4 of which switched to daratumumab SC and 3 stopped treatment before being able to switch. The safety information for the active arm is pooled together and includes all patients that received DPd (n=149) but also shown separately [D(IV)Pd (n=3), D(IV/SC)Pd (n=4), D(SC)Pd (n=142)].
Arm/Group Title	Pomalidomide + Dexamethasone	Daratumumab+Pomalidomide+Dexamethasone	Daratumumab (IV) +Pomalidomide+Dexamethasone	Daratumumab (IV/SC) +Pomalidomide+Dexamethasone	Daratumumab (SC)+Pomalidomide+Dexamethasone
Arm/Group Description	Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. 7 patients started receiving daratumumab IV (Protocol v1.0). The study was amended to change the administration from IV to SC. Of those 7 patients, 4 switched to SC (after having received a max of 6 cycles of IV treatment) and 3 discontinued treatment before the study was amended. All other dara-treated patients (142 of 149 DPd subjects) received only dara SC after the amendment. The safety information for the active arm is pooled together and includes all patients that received DPd (n=149) but also shown separately [D(IV)Pd (n=3), D(IV/SC)Pd (n=4), D(SC)Pd (n=142)].	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. 7 patients started receiving daratumumab IV (Protocol v1.0). The study was amended to change the administration from IV to SC. Of those 7 patients, 4 switched to SC (after having received a max of 6 cycles of IV treatment) and 3 discontinued treatment before the study was amended. All other dara-treated patients (142 of 149 DPd subjects) received only dara SC after the amendment. The safety information for the active arm is pooled together and includes all patients that received DPd (n=149) but also shown separately [D(IV)Pd (n=3), D(IV/SC)Pd (n=4), D(SC)Pd (n=142)].	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. 7 patients started receiving daratumumab IV (Protocol v1.0). The study was amended to change the administration from IV to SC. Of those 7 patients, 4 switched to SC (after having received a max of 6 cycles of IV treatment) and 3 discontinued treatment before the study was amended. All other dara-treated patients (142 of 149 DPd subjects) received only dara SC after the amendment. The safety information for the active arm is pooled together and includes all patients that received DPd (n=149) but also shown separately [D(IV)Pd (n=3), D(IV/SC)Pd (n=4), D(SC)Pd (n=142)].	Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. 7 patients started receiving daratumumab IV (Protocol v1.0). The study was amended to change the administration from IV to SC. Of those 7 patients, 4 switched to SC (after having received a max of 6 cycles of IV treatment) and 3 discontinued treatment before the study was amended. All other dara-treated patients (142 of 149 DPd subjects) received only dara SC after the amendment. The safety information for the active arm is pooled together and includes all patients that received DPd (n=149) but also shown separately [D(IV)Pd (n=3), D(IV/SC)Pd (n=4), D(SC)Pd (n=142)].
All-Cause Mortality
	Pomalidomide + Dexamethasone	Daratumumab+Pomalidomide+Dexamethasone	Daratumumab (IV) +Pomalidomide+Dexamethasone	Daratumumab (IV/SC) +Pomalidomide+Dexamethasone	Daratumumab (SC)+Pomalidomide+Dexamethasone
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	51/153 (33.33%)	48/151 (31.79%)	3/3 (100.00%)	2/4 (50.00%)	42/142 (29.58%)
Serious Adverse Events
	Pomalidomide + Dexamethasone	Daratumumab+Pomalidomide+Dexamethasone	Daratumumab (IV) +Pomalidomide+Dexamethasone	Daratumumab (IV/SC) +Pomalidomide+Dexamethasone	Daratumumab (SC)+Pomalidomide+Dexamethasone
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	59/150 (39.33%)	75/149 (50.34%)	2/3 (66.67%)	1/4 (25.00%)	72/142 (50.70%)
Blood and lymphatic system disorders
Febrile neutropenia *	3/150 (2.00%)	5/149 (3.36%)	0/3 (0.00%)	0/4 (0.00%)	5/142 (3.52%)
Thrombocytopenia *	1/150 (0.67%)	4/149 (2.68%)	0/3 (0.00%)	0/4 (0.00%)	4/142 (2.82%)
Neutropenia *	1/150 (0.67%)	2/149 (1.34%)	0/3 (0.00%)	0/4 (0.00%)	2/142 (1.41%)
Anaemia *	1/150 (0.67%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Bone marrow failure *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Leukopenia *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Cardiac disorders
Acute myocardial infarction *	1/150 (0.67%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Angina pectoris *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Cardiac failure *	1/150 (0.67%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Arrhythmia *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Atrial fibrillation *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Atrial flutter *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Myocardial infarction *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Myocardial ischaemia *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Eye disorders
Diplopia *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Gastrointestinal disorders
diarrhoea *	1/150 (0.67%)	3/149 (2.01%)	0/3 (0.00%)	0/4 (0.00%)	3/142 (2.11%)
Colitis ischaemic *	0/150 (0.00%)	2/149 (1.34%)	0/3 (0.00%)	0/4 (0.00%)	2/142 (1.41%)
Nausea *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Odynophagia *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Barrett's oesophagus *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Gastrointestinal haemorrhage *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Intestinal obstruction *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Upper gastrointestinal haemorrhage *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
General disorders
Pyrexia *	1/150 (0.67%)	3/149 (2.01%)	0/3 (0.00%)	0/4 (0.00%)	3/142 (2.11%)
General physical health deterioration *	3/150 (2.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Chills *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Sudden death *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Fatigue *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Hepatobiliary disorders
Liver disorder *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Cholecystitis *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Hepatocellular injury *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Infections and infestations
pneumonia *	12/150 (8.00%)	23/149 (15.44%)	0/3 (0.00%)	0/4 (0.00%)	23/142 (16.20%)
Lower respiratory tract infection *	14/150 (9.33%)	18/149 (12.08%)	0/3 (0.00%)	0/4 (0.00%)	18/142 (12.68%)
Upper respiratory tract infection *	3/150 (2.00%)	3/149 (2.01%)	0/3 (0.00%)	0/4 (0.00%)	3/142 (2.11%)
Bronchitis *	5/150 (3.33%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Urinary tract infection *	0/150 (0.00%)	2/149 (1.34%)	0/3 (0.00%)	0/4 (0.00%)	2/142 (1.41%)
Atypical pneumonia *	1/150 (0.67%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Campylobacter infection *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Diverticulitis *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Erysipelas *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Gastroenteritis *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Meningoencephalitis bacterial *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
COVID-19 *	0/150 (0.00%)	2/149 (1.34%)	0/3 (0.00%)	0/4 (0.00%)	2/142 (1.41%)
Influenza *	0/150 (0.00%)	2/149 (1.34%)	0/3 (0.00%)	0/4 (0.00%)	2/142 (1.41%)
Pneumonia respiratory syncytial viral *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Respiratory tract infection viral *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Sepsis *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Septic shock *	2/150 (1.33%)	1/149 (0.67%)	1/3 (33.33%)	0/4 (0.00%)	0/142 (0.00%)
Sinusitis *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Systemic candida *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Encephalitis viral *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Escherichia infection *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Gastrointestinal infection *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Leishmaniasis *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Meningitis listeria *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Pneumonia bacterial *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Viral infection *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Injury, poisoning and procedural complications
Lumbar vertebral fracture *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Fall *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Head injury *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Ilium fracture *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Investigations
C-reactive protein increased *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Eastern Cooperative Oncology Group performance status worsened *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Metabolism and nutrition disorders
Hypoglycaemia *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Musculoskeletal and connective tissue disorders
Arthralgia *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Intervertebral disc protrusion *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Borderline ovarian tumour *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Cholangiocarcinoma *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Malignant melanoma *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Adenocarcinoma of colon *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Metastatic renal cell carcinoma *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Tumour associated fever *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Nervous system disorders
Syncope *	0/150 (0.00%)	3/149 (2.01%)	0/3 (0.00%)	0/4 (0.00%)	3/142 (2.11%)
Cerebellar ataxia *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Cerebrovascular accident *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	1/4 (25.00%)	0/142 (0.00%)
Cerebral haemorrhage *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Cervicobrachial syndrome *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Dizziness *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Hypertensive hydrocephalus *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Psychiatric disorders
Confusional state *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Renal and urinary disorders
Acute kidney injury *	2/150 (1.33%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Renal failure *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Reproductive system and breast disorders
Benign prostatic hyperplasia *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea *	1/150 (0.67%)	3/149 (2.01%)	1/3 (33.33%)	0/4 (0.00%)	2/142 (1.41%)
Respiratory failure *	1/150 (0.67%)	2/149 (1.34%)	0/3 (0.00%)	0/4 (0.00%)	2/142 (1.41%)
Acute pulmonary oedema *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Acute respiratory failure *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Chronic obstructive pulmonary disease *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Pleural effusion *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Bronchiectasis *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Pneumonia aspiration *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Skin and subcutaneous tissue disorders
Pruritus *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Rash *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Rash maculo-papular *	1/150 (0.67%)	0/149 (0.00%)	0/3 (0.00%)	0/4 (0.00%)	0/142 (0.00%)
Vascular disorders
Anal haemorrhage *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Deep vein thrombosis *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Embolism *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Hypotension *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
Orthostatic hypotension *	0/150 (0.00%)	1/149 (0.67%)	0/3 (0.00%)	0/4 (0.00%)	1/142 (0.70%)
* Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5.0%
	Pomalidomide + Dexamethasone	Daratumumab+Pomalidomide+Dexamethasone	Daratumumab (IV) +Pomalidomide+Dexamethasone	Daratumumab (IV/SC) +Pomalidomide+Dexamethasone	Daratumumab (SC)+Pomalidomide+Dexamethasone
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	141/150 (94.00%)	143/149 (95.97%)	3/3 (100.00%)	4/4 (100.00%)	136/142 (95.77%)
Blood and lymphatic system disorders
Neutropenia *	80/150 (53.33%)	105/149 (70.47%)	1/3 (33.33%)	3/4 (75.00%)	101/142 (71.13%)
Anaemia *	66/150 (44.00%)	55/149 (36.91%)	1/3 (33.33%)	1/4 (25.00%)	53/142 (37.32%)
Thrombocytopenia *	50/150 (33.33%)	47/149 (31.54%)	1/3 (33.33%)	0/4 (0.00%)	46/142 (32.39%)
Leukopenia *	18/150 (12.00%)	39/149 (26.17%)	0/3 (0.00%)	1/4 (25.00%)	38/142 (26.76%)
Lymphopenia *	12/150 (8.00%)	22/149 (14.77%)	2/3 (66.67%)	1/4 (25.00%)	19/142 (13.38%)
Febrile neutropenia *	2/150 (1.33%)	9/149 (6.04%)	0/3 (0.00%)	1/4 (25.00%)	8/142 (5.63%)
Gastrointestinal disorders
Diarrhoea *	20/150 (13.33%)	33/149 (22.15%)	0/3 (0.00%)	1/4 (25.00%)	32/142 (22.54%)
Constipation *	22/150 (14.67%)	21/149 (14.09%)	0/3 (0.00%)	0/4 (0.00%)	21/142 (14.79%)
Nausea *	10/150 (6.67%)	10/149 (6.71%)	0/3 (0.00%)	0/4 (0.00%)	10/142 (7.04%)
Vomiting *	3/150 (2.00%)	8/149 (5.37%)	0/3 (0.00%)	0/4 (0.00%)	8/142 (5.63%)
General disorders
Fatigue *	37/150 (24.67%)	38/149 (25.50%)	2/3 (66.67%)	2/4 (50.00%)	34/142 (23.94%)
Asthenia *	24/150 (16.00%)	33/149 (22.15%)	0/3 (0.00%)	0/4 (0.00%)	33/142 (23.24%)
Pyrexia *	21/150 (14.00%)	26/149 (17.45%)	0/3 (0.00%)	1/4 (25.00%)	25/142 (17.61%)
Oedema peripheral *	11/150 (7.33%)	22/149 (14.77%)	0/3 (0.00%)	1/4 (25.00%)	21/142 (14.79%)
Infections and infestations
Upper respiratory tract infection *	23/150 (15.33%)	31/149 (20.81%)	1/3 (33.33%)	2/4 (50.00%)	28/142 (19.72%)
Pneumonia *	9/150 (6.00%)	10/149 (6.71%)	0/3 (0.00%)	0/4 (0.00%)	10/142 (7.04%)
Lower respiratory tract infection *	11/150 (7.33%)	20/149 (13.42%)	0/3 (0.00%)	1/4 (25.00%)	19/142 (13.38%)
Bronchitis *	16/150 (10.67%)	19/149 (12.75%)	0/3 (0.00%)	0/4 (0.00%)	19/142 (13.38%)
Nasopharyngitis *	8/150 (5.33%)	12/149 (8.05%)	0/3 (0.00%)	0/4 (0.00%)	12/142 (8.45%)
Pharyngitis *	0/150 (0.00%)	8/149 (5.37%)	0/3 (0.00%)	0/4 (0.00%)	8/142 (5.63%)
Investigations
Eastern Cooperative Oncology Group performance status worsened *	13/150 (8.67%)	7/149 (4.70%)	0/3 (0.00%)	0/4 (0.00%)	7/142 (4.93%)
Metabolism and nutrition disorders
Hyperglycaemia *	19/150 (12.67%)	15/149 (10.07%)	0/3 (0.00%)	2/4 (50.00%)	13/142 (9.15%)
Hypocalcaemia *	9/150 (6.00%)	13/149 (8.72%)	0/3 (0.00%)	1/4 (25.00%)	12/142 (8.45%)
Hypokalaemia *	7/150 (4.67%)	12/149 (8.05%)	0/3 (0.00%)	0/4 (0.00%)	12/142 (8.45%)
Musculoskeletal and connective tissue disorders
Back pain *	14/150 (9.33%)	15/149 (10.07%)	0/3 (0.00%)	0/4 (0.00%)	15/142 (10.56%)
Bone pain *	19/150 (12.67%)	14/149 (9.40%)	0/3 (0.00%)	0/4 (0.00%)	14/142 (9.86%)
Muscle spasms *	7/150 (4.67%)	12/149 (8.05%)	1/3 (33.33%)	0/4 (0.00%)	11/142 (7.75%)
Muscular weakness *	5/150 (3.33%)	10/149 (6.71%)	0/3 (0.00%)	0/4 (0.00%)	10/142 (7.04%)
Pain in extremity *	10/150 (6.67%)	9/149 (6.04%)	0/3 (0.00%)	0/4 (0.00%)	9/142 (6.34%)
Musculoskeletal chest pain *	4/150 (2.67%)	8/149 (5.37%)	0/3 (0.00%)	0/4 (0.00%)	8/142 (5.63%)
Nervous system disorders
Tremor *	13/150 (8.67%)	15/149 (10.07%)	0/3 (0.00%)	1/4 (25.00%)	14/142 (9.86%)
Peripheral sensory neuropathy *	11/150 (7.33%)	14/149 (9.40%)	0/3 (0.00%)	2/4 (50.00%)	12/142 (8.45%)
Psychiatric disorders
Insomnia *	18/150 (12.00%)	12/149 (8.05%)	0/3 (0.00%)	1/4 (25.00%)	11/142 (7.75%)
Anxiety *	8/150 (5.33%)	4/149 (2.68%)	0/3 (0.00%)	0/4 (0.00%)	4/142 (2.82%)
Respiratory, thoracic and mediastinal disorders
Cough *	10/150 (6.67%)	17/149 (11.41%)	0/3 (0.00%)	0/4 (0.00%)	17/142 (11.97%)
Dyspnoea *	10/150 (6.67%)	15/149 (10.07%)	0/3 (0.00%)	0/4 (0.00%)	15/142 (10.56%)
Skin and subcutaneous tissue disorders
Rash *	8/150 (5.33%)	10/149 (6.71%)	0/3 (0.00%)	0/4 (0.00%)	10/142 (7.04%)
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Sarah Lonergan, Trial lead
• Organization: EMN
• Phone: +44 7767565020
• EMail: sarah.lonergan@emn.life

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

He J, Berringer H, Heeg B, Ruan H, Kampfenkel T, Dwarakanathan HR, Johnston S, Mendes J, Lam A, Bathija S, Mackay EK. Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma. Adv Ther. 2022 Sep;39(9):4230-4249. doi: 10.1007/s12325-022-02226-x. Epub 2022 Jul 22.

Dimopoulos MA, Terpos E, Boccadoro M, Delimpasi S, Beksac M, Katodritou E, Moreau P, Baldini L, Symeonidis A, Bila J, Oriol A, Mateos MV, Einsele H, Orfanidis I, Ahmadi T, Ukropec J, Kampfenkel T, Schecter JM, Qiu Y, Amin H, Vermeulen J, Carson R, Sonneveld P; APOLLO Trial Investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jun;22(6):801-812. doi: 10.1016/S1470-2045(21)00128-5.

• Responsible Party: Stichting European Myeloma Network
• ClinicalTrials.gov Identifier: NCT03180736
• Other Study ID Numbers: EMN14/54767414MMY3013
• First Submitted: May 30, 2017
• First Posted: June 8, 2017
• Results First Submitted: April 13, 2021
• Results First Posted: May 11, 2022
• Last Update Posted: May 11, 2022