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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)

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ClinicalTrials.gov Identifier: NCT03180736
Recruitment Status : Active, not recruiting
First Posted : June 8, 2017
Results First Posted : May 11, 2022
Last Update Posted : May 11, 2022
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
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
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
Hide 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
Arm/Group Title Daratumumab+Pomalidomide+Dexamethasone Pomalidomide + Dexamethasone Total
Hide 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
Hide 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%
1.Primary Outcome
Title Comparison of Progression Free Survival Between Treatment Arms
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daratumumab+Pomalidomide+Dexamethasone Pomalidomide + Dexamethasone
Hide 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
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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%) 
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Sarah Lonergan, Trial lead
Organization: EMN
Phone: +44 7767565020
EMail: sarah.lonergan@emn.life
Layout table for additonal information
Responsible Party: 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