Open Label Study to Evaluate the Safety and Efficacy of L... | NCT02399085

ID	Type	Description	Link
2014-004688-19	EudraCT Number

Label	Type	Description	Intervention Names
Tafasitamab (MOR00208) + lenalidomide (LEN)	Experimental	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.	Drug: Tafasitamab Drug: Lenalidomide

Name	Type	Description	Arm Group Labels	Other Names
Tafasitamab	Drug	12 mg/kg	Tafasitamab (MOR00208) + lenalidomide (LEN)

Measure	Description	Time Frame
Number of Participants With Best Objective Response Rate (ORR)	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.	Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Measure	Description	Time Frame
Duration of Response (DoR) by IRC Evaluation	DoR [months] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.	Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Eligibility Module

Eligibility Criteria

Major Inclusion Criteria:

Age >18 years
Histologically confirmed diagnosis of DLBCL
Tumour tissue for central pathology review and correlative studies had to be provided.
Participants must had:
- relapsed and/or refractory disease
- at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
- received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must had included a CD20-targeted therapy
- Eastern Cooperative Oncology Group 0 to 2
Participants were not considered in the opinion of the investigator eligible, or participants unwilling to undergo intensive salvage therapy including ASCT
Participants had to meet the following laboratory criteria at screening:
- absolute neutrophil count ≥1.5 × 10˄9/L
- platelet count ≥90 × 10˄9/L
- total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
- alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or <5 × ULN in cases of liver involvement
- serum creatinine clearance ≥60 mL/minute
Females of childbearing potential (FCBP) must:
- not be pregnant
- refrain from breastfeeding and donating blood or oocytes
- agreed to ongoing pregnancy testing
- committed to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
Males (if sexually active with a FCBP) had to
- use an effective barrier method of contraception
- refrain from donating blood or sperm
In the opinion of the investigator the participants had to:
- be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
- be able to understand, give written informed consent and comply with all study-related procedures, medication use, and evaluations
- had no history of noncompliance in relation to medical regimens or not be considered potentially unreliable and/or uncooperative
- be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and gave written acknowledgement of this.

Major Exclusion Criteria:

Participants who had:
- other histological type of lymphoma
- primary refractory DLBCL
- a history of "double/triple hit" genetics
Participants who had, within 14 days prior to Day 1 dosing:
- not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
- underwent major surgery or suffered from significant traumatic injury
- received live vaccines.
- required parenteral antimicrobial therapy for active, intercurrent infections
Participants who:
- had, in the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies
- were previously treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs)® (e.g., thalidomide, LEN)
- had a history of hypersensitivity to compounds of similar biological or chemical composition to MOR00208, IMiDs® and/or the excipients contained in the study drug formulations
- had undergone ASCT within the period ≤ 3 months prior to the signing of the Informed Consent Form. Patients who had a more distant history of ASCT had to exhibit full haematological recovery before enrolment into the study
- had undergone previous allogenic stem cell transplantation
- had a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or were at a high risk for a thromboembolic event in the opinion of the investigator and who were not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
- concurrently used other anti-cancer or experimental treatments
Prior history of malignancies other than DLBCL, unless the participant had been free of the disease for ≥5 years prior to screening.
Participants with:
- positive hepatitis B and/or C serology.
- known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
- CNS lymphoma involvement
- history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromised the participant's ability to give informed consent.

Name	Affiliation	Role
Johannes Duell, MD	MorphoSys AG	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center		Bakersfield	California	93309	United States

PubMed Identifier	Type	Citation	Retractions
32511983	Result	Salles G, Duell J, Gonzalez Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, Andre M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5.
34196165

Label	URL
CD19 expression is maintained in DLBCL patients after treatment with tafasitamab plus lenalidomide in the L-MIND study	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 24, 2021	Jul 21, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Best Objective Response Rate (ORR)

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.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG00080

Title

Denominators

Categories

Approximately 4.5 years after first participant enrolled

Title	Measurements
	OG00046

Approximately 6.5 years after first participant enrolled

Title	Measurements
	OG00046

Secondary

Duration of Response (DoR) by IRC Evaluation

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

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.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

DoR by Investigator (INV) Evaluation

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

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Units	Counts
Participants

Secondary

Progression-free Survival (PFS) by IRC Evaluation

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.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Units

Secondary

PFS by INV Evaluation

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.

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.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Units	Counts

Secondary

Overall Survival (OS)

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).

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.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Units	Counts

Secondary

Disease Control Rate (DCR) by IRC Evaluation

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.

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.

Posted

Count of Participants

Participants

Approximately 2.5 years after first participant enrolled

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Units	Counts

Secondary

DCR by INV Evaluation

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.

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.

Posted

Count of Participants

Participants

Approximately 2.5 years after first participant enrolled

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Units	Counts
Participants

Secondary

Time to Progression (TTP) by IRC Evaluation

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.

Posted

Median

95% Confidence Interval

Months

Approximately 2.5 years after first participant enrolled

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Units	Counts

Secondary

TTP by INV Evaluation

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.

Posted

Median

95% Confidence Interval

Months

Approximately 2.5 years after first participant enrolled

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Units	Counts
Participants

Secondary

Time to Next Treatment (TTNT)

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.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Secondary

Event-free Survival (EFS) by IRC Evaluation

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.

Posted

Median

95% Confidence Interval

Months

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

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Secondary

Serum Drug Levels of MOR00208

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).

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.

Posted

Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Secondary

Number of Participants Who Developed Anti-MOR00208 Antibodies

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).

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

Posted

Count of Participants

Participants

Baseline, Up to a maximum of 23 cycles.

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Secondary

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

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.

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.

Posted

Count of Participants

Participants

Approximately 6.5 years after first participant enrolled

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Secondary

Severity of Treatment-emergent Adverse Events (TEAEs)

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

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.

Posted

Count of Participants

Participants

Approximately 6.5 years after first participant enrolled

ID	Title	Description
OG000	Tafasitamab (MOR00208) + Lenalidomide (LEN)	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.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0007 events7 affected81 at risk
Bronchitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected81 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected81 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Enterobacter bacteraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Febrile infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Influenza	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0004 events2 affected81 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Progressive multifocal leukoencephalopathy	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected81 at risk
Soft tissue infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected81 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected81 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected81 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected81 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Cognitive disorder	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Facial paralysis	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Sciatica	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Transient global amnesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected81 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected81 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected81 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Sudden death	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected81 at risk
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Renal failure	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected81 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected81 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected81 at risk
Haematoma	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Intervertebral discitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected81 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG000215 events40 affected81 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG00074 events30 affected81 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG00071 events23 affected81 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG00044 events10 affected81 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0006 events5 affected81 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG00010 events5 affected81 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00063 events30 affected81 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00021 events15 affected81 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00021 events12 affected81 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00015 events12 affected81 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0009 events8 affected81 at risk
Asthenia	General disorders	MedDRA 25.1	Systematic Assessment	EG00039 events21 affected81 at risk
Oedema peripheral	General disorders	MedDRA 25.1	Systematic Assessment	EG00035 events20 affected81 at risk
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG00039 events18 affected81 at risk
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG00024 events13 affected81 at risk
Mucosal inflammation	General disorders	MedDRA 25.1	Systematic Assessment	EG0009 events6 affected81 at risk
Bronchitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00019 events12 affected81 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00011 events8 affected81 at risk
Respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00017 events9 affected81 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0009 events8 affected81 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00015 events10 affected81 at risk
Gastroenteritis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0009 events6 affected81 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG00020 events18 affected81 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG00028 events15 affected81 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG00026 events8 affected81 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG00016 events5 affected81 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG00019 events16 affected81 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG00016 events12 affected81 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG000913 events8 affected81 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG00011 events6 affected81 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00036 events24 affected81 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG00016 events10 affected81 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0006 events6 affected81 at risk
C-reactive protein increased	Investigations	MedDRA 25.1	Systematic Assessment	EG00012 events9 affected81 at risk
Blood creatinine increased	Investigations	MedDRA 25.1	Systematic Assessment	EG00017 events7 affected81 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0009 events6 affected81 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0009 events8 affected81 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG00010 events8 affected81 at risk
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG00019 events7 affected81 at risk
Paraesthesia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0007 events7 affected81 at risk
Hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG00010 events7 affected81 at risk
Hypotension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0006 events6 affected81 at risk
Anxiety	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG00010 events6 affected81 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected81 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected81 at risk
Dysuria	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected81 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0009 events5 affected81 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected81 at risk
Sciatica	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0008 events5 affected81 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected81 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG00018 events5 affected81 at risk
Rhinitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0007 events7 affected81 at risk
Sinusitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0007 events6 affected81 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0008 events6 affected81 at risk

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring