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A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL (L-MIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02399085
Recruitment Status : Active, not recruiting
First Posted : March 26, 2015
Results First Posted : February 5, 2020
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diffuse Large B-cell Lymphoma
Interventions Drug: MOR00208
Drug: Lenalidomide
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (MOR00208, Lenalidomide)
Hide Arm/Group Description

MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.

MOR00208: 12 mg/kg

Lenalidomide: 25 mg

Period Title: Overall Study
Started 81
Completed 30 [1]
Not Completed 51
[1]
30 patients completed the combination treatment on both study drugs (12 cycles).
Arm/Group Title Treatment (MOR00208, Lenalidomide)
Hide Arm/Group Description

MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.

MOR00208: 12 mg/kg

Lenalidomide: 25 mg

Overall Number of Baseline Participants 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
  28.4%
>=65 years
58
  71.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants
69.3  (9.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
Female
37
  45.7%
Male
44
  54.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
72
  88.9%
More than one race
0
   0.0%
Unknown or Not Reported
7
   8.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
Hungary
7
   8.6%
Belgium
5
   6.2%
United States
6
   7.4%
Czechia
3
   3.7%
Poland
7
   8.6%
Italy
13
  16.0%
United Kingdom
5
   6.2%
France
9
  11.1%
Germany
11
  13.6%
Spain
15
  18.5%
1.Primary Outcome
Title Number of Participants With Best Objective Response Rate
Hide Description ORR = complete response [CR] + partial response [PR]; IRC Evaluation
Time Frame 1-3 years approximately
Hide Outcome Measure Data
Hide Analysis Population Description
Response Criteria are based on International Working Group Response Criteria: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), >=50% regression of measurable disease and no new sites. 80 of 81 patients enrolled in this study received MOR208 plus lenalidomide and represent efficacy set.
Arm/Group Title Treatment (MOR00208, Lenalidomide)
Hide Arm/Group Description:

MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.

MOR00208: 12 mg/kg

Lenalidomide: 25 mg

Overall Number of Participants Analyzed 80
Measure Type: Count of Participants
Unit of Measure: Participants
48
  60.0%
2.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR = CR + PR + SD; IRC Evaluation
Time Frame 1-3 years approximately
Hide Outcome Measure Data
Hide Analysis Population Description
Disease control rate (DCR) is defined as the proportion of patients having CR or PR or stable disease (SD) (DCR = ORR + SD). 80 of 81 patients enrolled in this study received MOR208 plus lenalidomide and represent efficacy set.
Arm/Group Title Treatment (MOR00208, Lenalidomide)
Hide Arm/Group Description:

MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.

MOR00208: 12 mg/kg

Lenalidomide: 25 mg

Overall Number of Participants Analyzed 80
Measure Type: Count of Participants
Unit of Measure: Participants
59
  73.8%
3.Secondary Outcome
Title Duration of Response (DoR)
Hide Description IRC Evaluation
Time Frame 1-3 years approximately
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of response (DoR) is defined as the time between the first response (CR or PR) and the first time point of radiologically confirmed disease progression. 80 of 81 patients enrolled in this study received MOR208 plus lenalidomide and represent efficacy set.
Arm/Group Title Treatment (MOR00208, Lenalidomide)
Hide Arm/Group Description:

MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.

MOR00208: 12 mg/kg

Lenalidomide: 25 mg

Overall Number of Participants Analyzed 80
Median (95% Confidence Interval)
Unit of Measure: months
21.7 [1] 
(21.7 to NA)
[1]
Not Reached / Not Estimable.
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description IRC Evaluation
Time Frame 1-3 years approximately
Hide Outcome Measure Data
Hide Analysis Population Description
Progression-free survival (PFS) is defined as the time between first IMP dosing and tumour progression or death from any cause, whichever occurs first. 80 of 81 patients enrolled in this study received MOR208 plus lenalidomide and represent efficacy set.
Arm/Group Title Treatment (MOR00208, Lenalidomide)
Hide Arm/Group Description:

MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.

MOR00208: 12 mg/kg

Lenalidomide: 25 mg

Overall Number of Participants Analyzed 80
Median (95% Confidence Interval)
Unit of Measure: months
12.1 [1] 
(5.7 to NA)
[1]
Not Reached / Not Estimable.
5.Secondary Outcome
Title Percentage of Participants With Overall Survival (OS)
Hide Description Overall survival was defined as first administration of IMP and deaths due to any cause. Percentage of patients alive at 12 months from the start of their study participation is reported.
Time Frame Approximately 32 months between first patient first visit and primary outcome completion date
Hide Outcome Measure Data
Hide Analysis Population Description
Overall survival was defined as first administration of IMP and deaths due to any cause. 80 of 81 patients enrolled in this study received MOR208 plus lenalidomide and represent efficacy set.
Arm/Group Title Treatment (MOR00208, Lenalidomide)
Hide Arm/Group Description:

MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.

MOR00208: 12 mg/kg

Lenalidomide: 25 mg

Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Percentage of partipants
74
Time Frame Treatment-emergent AEs were defined as any AE reported between the date of first administration of study treatment up to 30 days after last administration of study treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (MOR00208, Lenalidomide)
Hide Arm/Group Description

MOR00208 Fc-Optimized Anti-CD19 Antibody, intravenous Infusion, weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), 4 week cycles, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

Lenalidomide (Revlimid®), PO, daily, 4 week cycles, lenalidomide is used 3 of the 4 weeks. Up to 12 cycles in the absence of disease progression or unacceptable toxicity.

MOR00208: 12 mg/kg

Lenalidomide: 25 mg

All-Cause Mortality
Treatment (MOR00208, Lenalidomide)
Affected / at Risk (%)
Total   30/81 (37.04%)    
Hide Serious Adverse Events
Treatment (MOR00208, Lenalidomide)
Affected / at Risk (%) # Events
Total   41/81 (50.62%)    
Blood and lymphatic system disorders   
Febrile neutropenia   5/81 (6.17%)  5
Agranulocytosis   1/81 (1.23%)  2
Cardiac disorders   
Atrial fibrillation   2/81 (2.47%)  2
Cardiac failure congestive   2/81 (2.47%)  2
Cardiac failure   1/81 (1.23%)  1
Myocardial ischaemia   1/81 (1.23%)  1
Gastrointestinal disorders   
Diarrhoea   1/81 (1.23%)  1
General disorders   
Fatigue   1/81 (1.23%)  1
Pyrexia   1/81 (1.23%)  1
Sudden death   1/81 (1.23%)  1
Hepatobiliary disorders   
Biliary colic   1/81 (1.23%)  1
Infections and infestations   
Pneumonia   5/81 (6.17%)  5
Bronchitis   2/81 (2.47%)  2
Bronchopulmonary aspergillosis   1/81 (1.23%)  2
Cytomegalovirus infection   1/81 (1.23%)  1
Enterobacter bacteraemia   1/81 (1.23%)  1
Escherichia bacteraemia   1/81 (1.23%)  1
Febrile infection   1/81 (1.23%)  1
Influenza   1/81 (1.23%)  1
Klebsiella sepsis   1/81 (1.23%)  1
Lower respiratory tract infection   1/81 (1.23%)  3
Neutropenic sepsis   1/81 (1.23%)  1
Parainfluenzae virus infection   1/81 (1.23%)  1
Progressive multifocal leukoencephalopathy   1/81 (1.23%)  1
Respiratory syncytial virus infection   1/81 (1.23%)  1
Sepsis   1/81 (1.23%)  2
Soft tissue infection   1/81 (1.23%)  1
Streptococcal sepsis   1/81 (1.23%)  1
Urinary tract infection   1/81 (1.23%)  1
Urinary tract infection enterococcal   1/81 (1.23%)  1
Varicella zoster virus infection   1/81 (1.23%)  1
Injury, poisoning and procedural complications   
Femur fracture   1/81 (1.23%)  1
Lower limb fracture   1/81 (1.23%)  1
Wound complication   1/81 (1.23%)  1
Musculoskeletal and connective tissue disorders   
Arthritis   1/81 (1.23%)  1
Muscular weakness   1/81 (1.23%)  1
Osteonecrosis   1/81 (1.23%)  1
Pathological fracture   1/81 (1.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma   1/81 (1.23%)  1
Tumour flare   1/81 (1.23%)  1
Nervous system disorders   
Cerebrovascular accident   1/81 (1.23%)  1
Cervicobrachial syndrome   1/81 (1.23%)  1
Cognitive disorder   1/81 (1.23%)  1
Facial paralysis   1/81 (1.23%)  1
Sciatica   1/81 (1.23%)  1
Transient global amnesia   1/81 (1.23%)  1
Renal and urinary disorders   
Renal failure   1/81 (1.23%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism   3/81 (3.70%)  3
Chronic obstructive pulmonary disease   1/81 (1.23%)  2
Dyspnoea   1/81 (1.23%)  1
Respiratory failure   1/81 (1.23%)  1
Vascular disorders   
Deep vein thrombosis   1/81 (1.23%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (MOR00208, Lenalidomide)
Affected / at Risk (%) # Events
Total   74/81 (91.36%)    
Blood and lymphatic system disorders   
Any TEAE   52/81 (64.20%)  392
Neutropenia   40/81 (49.38%)  192
Anaemia   28/81 (34.57%)  59
Thrombocytopenia   25/81 (30.86%)  72
Leukopenia   12/81 (14.81%)  48
Febrile neutropenia   5/81 (6.17%)  6
Lymphopenia   5/81 (6.17%)  15
Gastrointestinal disorders   
Any TEAE   45/81 (55.56%)  111
Diarrhoea   27/81 (33.33%)  51
Constipation   13/81 (16.05%)  17
Nausea   12/81 (14.81%)  20
Vomiting   11/81 (13.58%)  14
Abdominal pain   8/81 (9.88%)  9
General disorders   
Any TEAE   45/81 (55.56%)  117
Asthenia   19/81 (23.46%)  31
Oedema peripheral   18/81 (22.22%)  30
Pyrexia   16/81 (19.75%)  27
Fatigue   13/81 (16.05%)  21
Mucosal inflammation   6/81 (7.41%)  8
Immune system disorders   
Any TEAE   5/81 (6.17%)  5
Hypogammaglobulinaemia   5/81 (6.17%)  5
Infections and infestations   
Any TEAE   32/81 (39.51%)  55
Bronchitis   9/81 (11.11%)  13
Nasopharyngitis   8/81 (9.88%)  9
Respiratory tract infection   8/81 (9.88%)  10
Upper respiratory tract infection   8/81 (9.88%)  9
Urinary tract infection   6/81 (7.41%)  9
Gastroenteritis   5/81 (6.17%)  5
Injury, poisoning and procedural complications   
Any TEAE   5/81 (6.17%)  5
Infusion related reaction   5/81 (6.17%)  5
Investigations   
Any TEAE   15/81 (18.52%)  35
C-reactive protein increased   8/81 (9.88%)  11
Blood creatinine increased   7/81 (8.64%)  17
Gamma-glutamyltransferase increased   5/81 (6.17%)  7
Metabolism and nutrition disorders   
Any TEAE   31/81 (38.27%)  76
Decreased appetite   16/81 (19.75%)  18
Hypokalaemia   15/81 (18.52%)  25
Hypomagnesaemia   8/81 (9.88%)  17
Hypocalcaemia   5/81 (6.17%)  16
Musculoskeletal and connective tissue disorders   
Any TEAE   30/81 (37.04%)  48
Back pain   14/81 (17.28%)  16
Muscle spasms   12/81 (14.81%)  16
Pain in extremity   7/81 (8.64%)  9
Arthralgia   6/81 (7.41%)  7
Nervous system disorders   
Any TEAE   13/81 (16.05%)  18
Headache   7/81 (8.64%)  12
Paraesthesia   6/81 (7.41%)  6
Psychiatric disorders   
Any TEAE   6/81 (7.41%)  8
Anxiety   6/81 (7.41%)  8
Respiratory, thoracic and mediastinal disorders   
Any TEAE   25/81 (30.86%)  44
Cough   18/81 (22.22%)  24
Dyspnoea   10/81 (12.35%)  15
Oropharyngeal pain   5/81 (6.17%)  5
Skin and subcutaneous tissue disorders   
Any TEAE   14/81 (17.28%)  17
Pruritus   8/81 (9.88%)  9
Rash   6/81 (7.41%)  8
Vascular disorders   
Any TEAE   12/81 (14.81%)  14
Hypertension   7/81 (8.64%)  9
Hypotension   5/81 (6.17%)  5
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sumeet Ambarkhane, Director, Clinical Program Leader
Organization: MorphoSys AG
Phone: +49 89 89927 26841
EMail: Sumeet.Ambarkhane@morphosys.com
Layout table for additonal information
Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT02399085    
Other Study ID Numbers: MOR208C203
First Submitted: March 13, 2015
First Posted: March 26, 2015
Results First Submitted: November 27, 2019
Results First Posted: February 5, 2020
Last Update Posted: February 6, 2020