Trial Outcomes & Findings for Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL (NCT NCT02399085)

NCT ID: NCT02399085

Last Updated: 2023-10-23

Results Overview

ORR = complete response \[CR\] + partial response \[PR\]; Independent Radiology/Clinical Review Committee (IRC) Evaluation. ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation. ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 81 participants
• Primary outcome timeframe: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
• Results posted on: 2023-10-23

Participant Flow

The participants were enrolled into this study at sites in Hungary, Belgium, Czechia, France, Poland, Italy, Germany, Spain, United Kingdom, and the United States.

Participant milestones

Measure	Treatment (MOR00208, Lenalidomide) MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.
Overall Study STARTED	81
Overall Study Received MOR00208 + LEN	80
Overall Study Received MOR00208 Only	1
Overall Study Completed: Participants Who Were Still on Treatment at EOS	8
Overall Study Not Completed: Participants Who Were no Longer Receiving Treatment at EOS	73
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	73

Reasons for withdrawal

Measure	Treatment (MOR00208, Lenalidomide) MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.
Overall Study Adverse Event	16
Overall Study Death	2
Overall Study Withdrawal by Subject	8
Overall Study Progressive disease/ Disease relapse	42
Overall Study Physician Decision	5

Baseline Characteristics

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

Baseline characteristics by cohort

Measure	Treatment (MOR00208, Lenalidomide) n=81 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants
Age, Continuous	69.3 years STANDARD_DEVIATION 9.53 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment Hungary	7 Participants n=5 Participants
Region of Enrollment Belgium	5 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants
Region of Enrollment Czechia	3 Participants n=5 Participants
Region of Enrollment Poland	7 Participants n=5 Participants
Region of Enrollment Italy	13 Participants n=5 Participants
Region of Enrollment United Kingdom	5 Participants n=5 Participants
Region of Enrollment France	9 Participants n=5 Participants
Region of Enrollment Germany	11 Participants n=5 Participants
Region of Enrollment Spain	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Population: Full analysis set (FAS): The FAS included all participant who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.

ORR = complete response [CR] + partial response [PR]; Independent Radiology/Clinical Review Committee (IRC) Evaluation.

ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation.

ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=80 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
Number of Participants With Best Objective Response Rate (ORR) Approximately 4.5 years after first participant enrolled	46 Participants
Number of Participants With Best Objective Response Rate (ORR) Approximately 6.5 years after first participant enrolled	46 Participants

SECONDARY outcome

Timeframe: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.

DoR [months] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=46 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
Duration of Response (DoR) by IRC Evaluation Approximately 4.5 years after first participant enrolled	43.9 Months Interval 26.1 to \[Not available\]. Upper limit not reached due to insufficient number of events at later stages of follow-up.
Duration of Response (DoR) by IRC Evaluation Approximately 6.5 years after first participant enrolled	NA Months Interval 33.8 to \[Not available\]. Median and upper limit not reached due to insufficient number of events at later stages of follow-up.

SECONDARY outcome

Timeframe: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.

DoR [months] = (date of assessment of tumour progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=52 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
DoR by Investigator (INV) Evaluation Approximately 4.5 years after first participant enrolled	43.9 Months Interval 13.9 to Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.
DoR by Investigator (INV) Evaluation Approximately 6.5 years after first participant enrolled	43.4 Months Interval 14.1 to Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.

SECONDARY outcome

Timeframe: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.

PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=42 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
Progression-free Survival (PFS) by IRC Evaluation Approximately 4.5 years after first participant enrolled	11.6 Months Interval 6.3 to 45.7
Progression-free Survival (PFS) by IRC Evaluation Approximately 6.5 years after first participant enrolled	11.6 Months Interval 5.7 to 45.7

SECONDARY outcome

Timeframe: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Population: FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.

PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=49 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
PFS by INV Evaluation Approximately 4.5 years after first participant enrolled	9.1 Months Interval 5.5 to 28.0
PFS by INV Evaluation Approximately 6.5 years after first participant enrolled	9.1 Months Interval 5.5 to 45.5

SECONDARY outcome

Timeframe: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Population: FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied at least once. Inclusive of participants with available data.

OS was defined as the time from the date of the first administration of any study drug until death from any cause (documented by the date of death).

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=44 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
Overall Survival (OS) Approximately 4.5 years after first participant enrolled	33.5 Months Interval 18.3 to Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.
Overall Survival (OS) Approximately 6.5 years after first participant enrolled	33.5 Months Interval 18.3 to Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.

SECONDARY outcome

Timeframe: Approximately 2.5 years after first participant enrolled

Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.

DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.

Outcome measures

Measure

Treatment (MOR00208, Lenalidomide) n=80 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

Disease Control Rate (DCR) by IRC Evaluation

59 Participants

SECONDARY outcome

Timeframe: Approximately 2.5 years after first participant enrolled

Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.

DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.

Outcome measures

Measure

Treatment (MOR00208, Lenalidomide) n=80 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

DCR by INV Evaluation

60 Participants

SECONDARY outcome

Timeframe: Approximately 2.5 years after first participant enrolled

Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.

TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.

Outcome measures

Measure

Treatment (MOR00208, Lenalidomide) n=35 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

Time to Progression (TTP) by IRC Evaluation

16.2 Months Interval 7.4 to Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.

SECONDARY outcome

Timeframe: Approximately 2.5 years after first participant enrolled

Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.

TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.

Outcome measures

Measure

Treatment (MOR00208, Lenalidomide) n=40 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

TTP by INV Evaluation

14.1 Months Interval 6.3 to Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.

SECONDARY outcome

Timeframe: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Population: FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied at least once. Inclusive of participants with available data.

Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=55 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
Time to Next Treatment (TTNT) Approximately 4.5 years after first participant enrolled	12.1 Months Interval 7.3 to 24.7
Time to Next Treatment (TTNT) Approximately 6.5 years after first participant enrolled	12.5 Months Interval 7.3 to 28.0

SECONDARY outcome

Timeframe: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Population: FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied at least once. Inclusive of participants with available data.

EFS is defined as the time (in months) from the date of the first administration of any study drug to the date of tumour progression, first initiation of a new non-study anti-neoplastic therapy or death from any cause whichever comes first.

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=55 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
Event-free Survival (EFS) by IRC Evaluation Approximately 4.5 years after first participant enrolled	8.7 Months Interval 5.3 to 21.0
Event-free Survival (EFS) by IRC Evaluation Approximately 6.5 years after first participant enrolled	9.1 Months Interval 5.3 to 23.5

SECONDARY outcome

Timeframe: Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment

Population: PK analysis set (PKAS): The PKAS included all participants who received at least one dose of MOR00208 and had at least one quantifiable MOR00208 serum concentration. Number analyzed includes only participants with data at each timepoint.

The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling.

MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=81 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
Serum Drug Levels of MOR00208 Cycle 1 Day 1 (Predose)	6.7 ng/mL Standard Deviation 53.09
Serum Drug Levels of MOR00208 Cycle 1 Day 1 (1 hour post dose)	249075.9 ng/mL Standard Deviation 53724.93
Serum Drug Levels of MOR00208 Cycle 1 Day 4 (pre-dose)	126306.8 ng/mL Standard Deviation 39105.37
Serum Drug Levels of MOR00208 Cycle 1 Day 4 (1 hour post-dose)	363626.2 ng/mL Standard Deviation 82971.54
Serum Drug Levels of MOR00208 Cycle 1 Day 15 (pre dose)	157722.3 ng/mL Standard Deviation 50655.86
Serum Drug Levels of MOR00208 Cycle 1 Day 15 (1 hour post-dose)	396262.1 ng/mL Standard Deviation 97215.09
Serum Drug Levels of MOR00208 Cycle 2 Day 1 (predose)	181870.8 ng/mL Standard Deviation 72582.62
Serum Drug Levels of MOR00208 Cycle 2 Day 1 (1 hour post-dose)	439788.2 ng/mL Standard Deviation 126930.55
Serum Drug Levels of MOR00208 Cycle 2 Day 15 (Pre Dose)	217846.9 ng/mL Standard Deviation 77799.93
Serum Drug Levels of MOR00208 Cycle 2 Day 15 (1 hour post-dose) )	442940.2 ng/mL Standard Deviation 85475.90
Serum Drug Levels of MOR00208 Cycle 3 Day 1 (predose)	208520.6 ng/mL Standard Deviation 68866.46
Serum Drug Levels of MOR00208 Cycle 3 Day 1 (1 hour post-dose)	466135.8 ng/mL Standard Deviation 112647.31
Serum Drug Levels of MOR00208 Cycle 3 Day 15 (predose)	223909.4 ng/mL Standard Deviation 85170.91
Serum Drug Levels of MOR00208 Cycle 3 Day 15 (1 hour post-dose)	455635.0 ng/mL Standard Deviation 104198.64
Serum Drug Levels of MOR00208 Cycle 4 Day 1 (predose) )	216328.4 ng/mL Standard Deviation 94553.25
Serum Drug Levels of MOR00208 Cycle 5 Day 1 (pre dose)	142134.4 ng/mL Standard Deviation 72691.16
Serum Drug Levels of MOR00208 Cycle 6 Day 1 (pre dose)	115132.3 ng/mL Standard Deviation 55774.77
Serum Drug Levels of MOR00208 Cycle 7 Day 1 (pre dose)	114661.5 ng/mL Standard Deviation 73328.15
Serum Drug Levels of MOR00208 Cycle 9 Day 1 (pre dose)	108640.4 ng/mL Standard Deviation 52282.72
Serum Drug Levels of MOR00208 Cycle 11 Day 1 (pre dose)	126472.0 ng/mL Standard Deviation 64872.47
Serum Drug Levels of MOR00208 Cycle 13 Day 1 (pre dose)	100853.5 ng/mL Standard Deviation 61229.42
Serum Drug Levels of MOR00208 Cycle 15 Day 1 (pre dose)	159676.5 ng/mL Standard Deviation 61199.32
Serum Drug Levels of MOR00208 Cycle 17 Day 1 (pre dose)	175855.1 ng/mL Standard Deviation 64592.17
Serum Drug Levels of MOR00208 Cycle 19 Day 1 (pre dose)	197045.0 ng/mL Standard Deviation 69962.05
Serum Drug Levels of MOR00208 Cycle 21 Day 1 (pre dose)	197228.0 ng/mL Standard Deviation 53222.03
Serum Drug Levels of MOR00208 Cycle 23 Day 1 (pre dose)	224253.3 ng/mL Standard Deviation 64686.85
Serum Drug Levels of MOR00208 End of Treatment	141240.7 ng/mL Standard Deviation 114804.40

SECONDARY outcome

Timeframe: Baseline, Up to a maximum of 23 cycles.

Population: Immunogenicity analysis set (IAS): The IAS included participants who had at least one anti-MOR00208 antibody assessment.

The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23).

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=81 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
Number of Participants Who Developed Anti-MOR00208 Antibodies Yes (Treatment-emergent ADAs)	0 Participants
Number of Participants Who Developed Anti-MOR00208 Antibodies No (Negative baseline and post baseline results)	72 Participants
Number of Participants Who Developed Anti-MOR00208 Antibodies Not evaluable (Positive baseline results)	2 Participants
Number of Participants Who Developed Anti-MOR00208 Antibodies Missing (No post baseline results available)	7 Participants

SECONDARY outcome

Timeframe: Approximately 6.5 years after first participant enrolled

Population: Safety analysis set (SAF): The SAF includes all participants who received at least one dose of MOR00208 or LEN and had at least one post-baseline safety assessment.

TEAEs are defined as any adverse event reported in the following time interval (including the lower and upper limits): date of first administration of study treatment; date of last administration of study treatment + 30 days, or if they are considered to be related to the study drug.

Outcome measures

Measure

Treatment (MOR00208, Lenalidomide) n=81 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs)

81 Participants

SECONDARY outcome

Timeframe: Approximately 6.5 years after first participant enrolled

Population: SAF: The SAF includes all participants who received at least one dose of MOR00208 or LEN and had at least one post-baseline safety assessment.

Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy.

Outcome measures

Measure	Treatment (MOR00208, Lenalidomide) n=81 Participants MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
Severity of Treatment-emergent Adverse Events (TEAEs) Severe	43 Participants
Severity of Treatment-emergent Adverse Events (TEAEs) Moderate	31 Participants
Severity of Treatment-emergent Adverse Events (TEAEs) Mild	6 Participants
Severity of Treatment-emergent Adverse Events (TEAEs) Missing	1 Participants

Adverse Events

Treatment (MOR00208, Lenalidomide)

Serious events: 47 serious events

Other events: 75 other events

Deaths: 45 deaths

Serious adverse events

Measure	Treatment (MOR00208, Lenalidomide) n=81 participants at risk MOR00208 was administered via intravenous Infusion, weekly (Cycle 1-3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle, until disease progression or unacceptable toxicity or discontinuation due to any other reason. Lenalidomide (Revlimid®), PO, daily, on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. Treatment with LEN was stopped in case of disease progression, or unacceptable toxicity, or discontinuation for any other reason. On days when both study drugs were given together, LEN was administered prior to tafasitamab.
Infections and infestations Pneumonia	8.6% 7/81 • Number of events 7 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Bronchitis	2.5% 2/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Bronchopulmonary aspergillosis	1.2% 1/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Cytomegalovirus infection	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Enterobacter bacteraemia	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Escherichia bacteraemia	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Febrile infection	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Influenza	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Klebsiella sepsis	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Lower respiratory tract infection	2.5% 2/81 • Number of events 4 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Neutropenic sepsis	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Parainfluenzae virus infection	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Progressive multifocal leukoencephalopathy	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Respiratory syncytial virus infection	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Sepsis	1.2% 1/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Soft tissue infection	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Streptococcal sepsis	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Urinary tract infection	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Urinary tract infection enterococcal	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Varicella zoster virus infection	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Blood and lymphatic system disorders Febrile neutropenia	6.2% 5/81 • Number of events 5 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Blood and lymphatic system disorders Agranulocytosis	1.2% 1/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Cardiac disorders Atrial fibrillation	2.5% 2/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Cardiac disorders Cardiac failure congestive	2.5% 2/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Cardiac disorders Myocardial ischaemia	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Nervous system disorders Cerebrovascular accident	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Nervous system disorders Cervicobrachial syndrome	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Nervous system disorders Cognitive disorder	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Nervous system disorders Facial paralysis	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Nervous system disorders Sciatica	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Nervous system disorders Transient global amnesia	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.7% 3/81 • Number of events 3 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 1/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 2/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
General disorders Fatigue	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
General disorders Pyrexia	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
General disorders Sudden death	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Injury, poisoning and procedural complications Femur fracture	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Injury, poisoning and procedural complications Lower limb fracture	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Injury, poisoning and procedural complications Wound complication	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	2.5% 2/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Gastrointestinal disorders Diarrhoea	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Hepatobiliary disorders Biliary colic	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Renal and urinary disorders Renal failure	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Vascular disorders Deep vein thrombosis	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations COVID-19	3.7% 3/81 • Number of events 3 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations COVID-19 pneumonia	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Gastroenteritis rotavirus	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.5% 2/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Nervous system disorders Transient ischaemic attack	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Hepatobiliary disorders Cholecystitis	1.2% 1/81 • Number of events 2 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Vascular disorders Haematoma	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Intervertebral discitis	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Respiratory tract infection	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Cardiac disorders Cardio-respiratory arrest	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Musculoskeletal and connective tissue disorders Arthritis	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Musculoskeletal and connective tissue disorders Muscular weakness	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Musculoskeletal and connective tissue disorders Osteonecrosis	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Musculoskeletal and connective tissue disorders Pathological fracture	1.2% 1/81 • Number of events 1 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.

Other adverse events

Measure	Treatment (MOR00208, Lenalidomide) n=81 participants at risk MOR00208 was administered via intravenous Infusion, weekly (Cycle 1-3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle, until disease progression or unacceptable toxicity or discontinuation due to any other reason. Lenalidomide (Revlimid®), PO, daily, on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. Treatment with LEN was stopped in case of disease progression, or unacceptable toxicity, or discontinuation for any other reason. On days when both study drugs were given together, LEN was administered prior to tafasitamab.
Blood and lymphatic system disorders Neutropenia	49.4% 40/81 • Number of events 215 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Blood and lymphatic system disorders Anaemia	37.0% 30/81 • Number of events 74 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Blood and lymphatic system disorders Thrombocytopenia	28.4% 23/81 • Number of events 71 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Blood and lymphatic system disorders Leukopenia	12.3% 10/81 • Number of events 44 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Blood and lymphatic system disorders Febrile neutropenia	6.2% 5/81 • Number of events 6 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Blood and lymphatic system disorders Lymphopenia	6.2% 5/81 • Number of events 10 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Gastrointestinal disorders Diarrhoea	37.0% 30/81 • Number of events 63 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Gastrointestinal disorders Constipation	18.5% 15/81 • Number of events 21 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Gastrointestinal disorders Nausea	14.8% 12/81 • Number of events 21 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Gastrointestinal disorders Vomiting	14.8% 12/81 • Number of events 15 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Gastrointestinal disorders Abdominal pain	9.9% 8/81 • Number of events 9 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
General disorders Asthenia	25.9% 21/81 • Number of events 39 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
General disorders Oedema peripheral	24.7% 20/81 • Number of events 35 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
General disorders Pyrexia	22.2% 18/81 • Number of events 39 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
General disorders Fatigue	16.0% 13/81 • Number of events 24 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
General disorders Mucosal inflammation	7.4% 6/81 • Number of events 9 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Bronchitis	14.8% 12/81 • Number of events 19 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Nasopharyngitis	9.9% 8/81 • Number of events 11 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Respiratory tract infection	11.1% 9/81 • Number of events 17 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Upper respiratory tract infection	9.9% 8/81 • Number of events 9 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Urinary tract infection	12.3% 10/81 • Number of events 15 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Gastroenteritis	7.4% 6/81 • Number of events 9 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Metabolism and nutrition disorders Decreased appetite	22.2% 18/81 • Number of events 20 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Metabolism and nutrition disorders Hypokalaemia	18.5% 15/81 • Number of events 28 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Metabolism and nutrition disorders Hypomagnesaemia	9.9% 8/81 • Number of events 26 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Metabolism and nutrition disorders Hypocalcaemia	6.2% 5/81 • Number of events 16 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Musculoskeletal and connective tissue disorders Back pain	19.8% 16/81 • Number of events 19 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Musculoskeletal and connective tissue disorders Muscle spasms	14.8% 12/81 • Number of events 16 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Musculoskeletal and connective tissue disorders Pain in extremity	9.9% 8/81 • Number of events 913 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 6/81 • Number of events 11 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Respiratory, thoracic and mediastinal disorders Cough	29.6% 24/81 • Number of events 36 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.3% 10/81 • Number of events 16 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.4% 6/81 • Number of events 6 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Investigations C-reactive protein increased	11.1% 9/81 • Number of events 12 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Investigations Blood creatinine increased	8.6% 7/81 • Number of events 17 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Investigations Gamma-glutamyltransferase increased	7.4% 6/81 • Number of events 9 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Skin and subcutaneous tissue disorders Pruritus	9.9% 8/81 • Number of events 9 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Skin and subcutaneous tissue disorders Rash	9.9% 8/81 • Number of events 10 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Nervous system disorders Headache	8.6% 7/81 • Number of events 19 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Nervous system disorders Paraesthesia	8.6% 7/81 • Number of events 7 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Vascular disorders Hypertension	8.6% 7/81 • Number of events 10 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Vascular disorders Hypotension	7.4% 6/81 • Number of events 6 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Psychiatric disorders Anxiety	7.4% 6/81 • Number of events 10 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Immune system disorders Hypogammaglobulinaemia	6.2% 5/81 • Number of events 5 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Injury, poisoning and procedural complications Infusion related reaction	6.2% 5/81 • Number of events 5 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Renal and urinary disorders Dysuria	6.2% 5/81 • Number of events 5 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Investigations Blood alkaline phosphatase increased	6.2% 5/81 • Number of events 9 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.2% 5/81 • Number of events 5 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Nervous system disorders Sciatica	6.2% 5/81 • Number of events 8 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Respiratory, thoracic and mediastinal disorders Productive cough	6.2% 5/81 • Number of events 5 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Metabolism and nutrition disorders Hyperglycaemia	6.2% 5/81 • Number of events 18 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Rhinitis	8.6% 7/81 • Number of events 7 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Infections and infestations Sinusitis	7.4% 6/81 • Number of events 7 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
Gastrointestinal disorders Abdominal pain upper	7.4% 6/81 • Number of events 8 • From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled. All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.

Additional Information

Lisa Walz

MorphoSys AG

Phone: +49 89 89927 26240

Email: Lisa.Walz@morphosys.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place