Trial Outcomes & Findings for Comparison of Pom and Dex in Subjects With RRMM Previously Treated With Len and a PI Dara/Pom/Dex vs Pom/Dex (NCT NCT03180736)

Last Updated: 2025-12-19

Results Overview

Progression Free Survival (PFS) is defined as the time, in months, from randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever comes first. PFS2 is defined as the time, in months, from randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever comes first, after the next line of therapy. PD is 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

304 participants

Primary outcome timeframe

PFS is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 3 years). PFS2 is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 5 years).

Results posted on

2025-12-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Daratumumab+Pomalidomide+Dexamethasone 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.	Pomalidomide + Dexamethasone 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 Study STARTED	151	153
Overall Study Treated	149	150
Overall Study COMPLETED	60	33
Overall Study NOT COMPLETED	91	120

Reasons for withdrawal

Reasons for withdrawal
Measure	Daratumumab+Pomalidomide+Dexamethasone 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.	Pomalidomide + Dexamethasone 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 Study Adverse Event	3	4
Overall Study Death	10	7
Overall Study Withdrawal by Subject	5	12
Overall Study Lost to Follow-up	1	0
Overall Study Lack of Efficacy	66	87
Overall Study Physician Decision	4	7
Overall Study randomized but not treated	2	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daratumumab+Pomalidomide+Dexamethasone n=151 Participants 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.	Pomalidomide + Dexamethasone n=153 Participants 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 n=304 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 9.57 • n=151 Participants	66.5 years STANDARD_DEVIATION 9.70 • n=153 Participants	66.0 years STANDARD_DEVIATION 9.63 • n=304 Participants
Sex: Female, Male Female	72 Participants n=151 Participants	71 Participants n=153 Participants	143 Participants n=304 Participants
Sex: Female, Male Male	79 Participants n=151 Participants	82 Participants n=153 Participants	161 Participants n=304 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Greece	53 participants n=151 Participants	44 participants n=153 Participants	97 participants n=304 Participants
Region of Enrollment Netherlands	5 participants n=151 Participants	4 participants n=153 Participants	9 participants n=304 Participants
Region of Enrollment Turkey	16 participants n=151 Participants	24 participants n=153 Participants	40 participants n=304 Participants
Region of Enrollment Belgium	7 participants n=151 Participants	9 participants n=153 Participants	16 participants n=304 Participants
Region of Enrollment Czechia	6 participants n=151 Participants	4 participants n=153 Participants	10 participants n=304 Participants
Region of Enrollment Denmark	1 participants n=151 Participants	1 participants n=153 Participants	2 participants n=304 Participants
Region of Enrollment Italy	19 participants n=151 Participants	20 participants n=153 Participants	39 participants n=304 Participants
Region of Enrollment Serbia	4 participants n=151 Participants	5 participants n=153 Participants	9 participants n=304 Participants
Region of Enrollment Germany	8 participants n=151 Participants	7 participants n=153 Participants	15 participants n=304 Participants
Region of Enrollment Spain	15 participants n=151 Participants	22 participants n=153 Participants	37 participants n=304 Participants
Region of Enrollment Poland	1 participants n=151 Participants	1 participants n=153 Participants	2 participants n=304 Participants
Region of Enrollment France	16 participants n=151 Participants	12 participants n=153 Participants	28 participants n=304 Participants
Stage of Disease (ISS) I	68 Participants n=151 Participants	69 Participants n=153 Participants	137 Participants n=304 Participants
Stage of Disease (ISS) II	50 Participants n=151 Participants	51 Participants n=153 Participants	101 Participants n=304 Participants
Stage of Disease (ISS) III	33 Participants n=151 Participants	33 Participants n=153 Participants	66 Participants n=304 Participants
No. of Prior Lines of Therapy 1	16 Participants n=151 Participants	18 Participants n=153 Participants	34 Participants n=304 Participants
No. of Prior Lines of Therapy 2-3	114 Participants n=151 Participants	113 Participants n=153 Participants	227 Participants n=304 Participants
No. of Prior Lines of Therapy ≥4	21 Participants n=151 Participants	22 Participants n=153 Participants	43 Participants n=304 Participants

PRIMARY outcome

Timeframe: PFS is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 3 years). PFS2 is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 5 years).

Population: The intent-to-treat (ITT) analysis set includes all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.

Outcome measures

Outcome measures
Measure	Daratumumab+Pomalidomide+Dexamethasone n=151 Participants 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.	Pomalidomide + Dexamethasone n=153 Participants 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
Comparison of Progression Free Survival Between Treatment Arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone) PFS2	24.41 months Interval 17.05 to 35.71	17.58 months Interval 13.57 to 21.98
Comparison of Progression Free Survival Between Treatment Arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone) Primary Efficacy of PFS	12.42 months Interval 8.34 to 19.32	6.93 months Interval 5.52 to 9.26

SECONDARY outcome

Timeframe: Approximately up to 3 years (assessed monthly from randomization until PD).

Population: The intent-to-treat (ITT) population was used for efficacy evaluations (total of 304 randomized subjects, 151 in the Daratumumab/Pomalidomide/Dexamethasone group and 153 in the Pomalidomide/Dexamethasone group).

Overall response rate is defined as the proportion of randomized participants who achieved a best response of PR or better using modified IMWG criteria.

Outcome measures

Outcome measures
Measure	Daratumumab+Pomalidomide+Dexamethasone n=151 Participants 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.	Pomalidomide + Dexamethasone n=153 Participants 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 Response Rate	68.87 percentage of participants Interval 60.84 to 76.15	46.41 percentage of participants Interval 38.32 to 54.64

SECONDARY outcome

Timeframe: MRD is assessed at the time of suspected CR/sCR and 6, 12, 18, 24, and every 12 months (yearly assessments ±3 months) post CR/sCR in subjects who maintain CR. or sCR, until PD.

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

Depth of response is the analysis of the Minimal Residual Disease (MRD) negativity rate at the sensitivity threshold of 10\^-5 for patients who have achieved CR or better and for patients with suspected CR/sCR.

Outcome measures

Outcome measures
Measure	Daratumumab+Pomalidomide+Dexamethasone n=151 Participants 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.	Pomalidomide + Dexamethasone n=153 Participants 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
Depth of Response	14.57 percentage of participants Interval 9.36 to 21.22	1.96 percentage of participants Interval 0.41 to 5.62

SECONDARY outcome

Timeframe: From informed consent until 30 days after last study treatment, assessed up to approximately 3 years.

Population: Subjects achieving a best objective response of PR or better from the intention-to-treat population.

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).

Outcome measures

Outcome measures
Measure	Daratumumab+Pomalidomide+Dexamethasone n=104 Participants 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.	Pomalidomide + Dexamethasone n=71 Participants 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
Duration of Response	NA months Interval 15.21 to Median and upper limit of 95% CI was not estimable due to short follow-up by participants".	15.90 months Interval 8.31 to 24.8

SECONDARY outcome

Timeframe: From randomization until the date to next anti-neoplastic therapy or death from any cause, whichever comes first (approximately up to 3 years)

Population: Intent-to-treat (ITT) analysis set: total of 304 randomized subjects (151 in the Daratumumab/Pomalidomide/Dexamethasone group and 153 in the Pomalidomide/Dexamethasone group).

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.

Outcome measures

Outcome measures
Measure	Daratumumab+Pomalidomide+Dexamethasone n=151 Participants 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.	Pomalidomide + Dexamethasone n=153 Participants 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
Time to Next Therapy	23.23 months Interval 13.8 to Upper limit of 95% CI was not estimable due to short follow-up by participants	11.83 months Interval 8.87 to 15.38

SECONDARY outcome

Timeframe: From randomization until death from any cause (up to 5 years)

Population: Final OS analysis with the CCO of 31 May 2022 and a median (range) follow-up of 39.6 (0.1-56.9) months

Overall survival is defined as the time, in months, from randomization to the date of death from any cause.

Outcome measures

Outcome measures
Measure	Daratumumab+Pomalidomide+Dexamethasone n=151 Participants 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.	Pomalidomide + Dexamethasone n=153 Participants 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 Survival	34.40 months Interval 23.69 to 40.25	23.72 months Interval 19.61 to 29.37

SECONDARY outcome

Timeframe: Approximately up to 3 years (assessed on Day 1 of each treatment cycle, at the end of treatment, and every 4 weeks post treatment until PD.

Population: Intent-to-treat (ITT) analysis set: total of 304 randomized subjects (151 in the Daratumumab/Pomalidomide/Dexamethasone group and 153 in the Pomalidomide/Dexamethasone group).

Outcome measures

Outcome measures
Measure	Daratumumab+Pomalidomide+Dexamethasone n=151 Participants 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.	Pomalidomide + Dexamethasone n=153 Participants 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
Health-related Quality of Life-Time to Worsening in EORTC QLQ-C30 Scale Scores	4.01 months Interval 2.2 to 7.59	3.84 months Interval 3.02 to 5.91

SECONDARY outcome

Timeframe: Approximately up to 3 years (assessed on Day 1 of each treatment cycle, at the end of treatment, and every 4 weeks post treatment until PD).

Population: Intent-to-treat (ITT) analysis set: total of 304 randomized subjects (151 in the Daratumumab/Pomalidomide/Dexamethasone group and 153 in the Pomalidomide/Dexamethasone group).

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"

Outcome measures

Outcome measures
Measure	Daratumumab+Pomalidomide+Dexamethasone n=151 Participants 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.	Pomalidomide + Dexamethasone n=153 Participants 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
Health-related Quality of Life-Time to Worsening in EQ-5D-5L Utility Score	7.39 months Interval 5.32 to 19.52	6.14 months Interval 3.88 to 13.14

SECONDARY outcome

Timeframe: Approximately up to 3 years (assessed on Day 1 of each treatment cycle, at the end of treatment, and every 4 weeks post treatment until PD).

Population: Intent-to-treat (ITT) analysis set: a total of 304 randomized subjects (151 in the Daratumumab/Pomalidomide/Dexamethasone group and 153 in the Pomalidomide/Dexamethasone group).

Outcome measures

Outcome measures
Measure	Daratumumab+Pomalidomide+Dexamethasone n=151 Participants 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.	Pomalidomide + Dexamethasone n=153 Participants 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
Health-related Quality of Life-Time to Worsening in EQ-5D-5L Visual Analogue Scale	3.78 months Interval 2.83 to 6.54	2.86 months Interval 1.94 to 3.71

Adverse Events

Pomalidomide+Dexamethasone

Serious events: 60 serious events

Other events: 144 other events

Deaths: 88 deaths

Daratumumab+Pomalidomide+Dexamethasone

Serious events: 80 serious events

Other events: 144 other events

Deaths: 82 deaths

Daratumumab (SC)+Pomalidomide+Dexamethasone

Serious events: 77 serious events

Other events: 137 other events

Deaths: 77 deaths

Daratumumab (IV)+Pomalidomide+Dexamethasone

Serious events: 3 serious events

Other events: 7 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Sarah Lonergan, Trial lead

EMN

Phone: +44 7767565020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place