L-MIND: A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL
Study Details
Study Description
Brief Summary
This is an open-label, multicentre study to characterize the safety and efficacy of the human anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment (MOR00208, lenalidomide) 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. |
Drug: MOR00208
12 mg/kg
Other Names:
Drug: Lenalidomide
25 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Best Objective Response Rate [1-3 years approximately]
ORR = complete response [CR] + partial response [PR]; IRC Evaluation
Secondary Outcome Measures
- Disease Control Rate (DCR) [1-3 years approximately]
DCR = CR + PR + SD; IRC Evaluation
- Duration of Response (DoR) [1-3 years approximately]
IRC Evaluation
- Progression-free Survival (PFS) [1-3 years approximately]
IRC Evaluation
- Percentage of Participants With Overall Survival (OS) [Approximately 32 months between first patient first visit and primary outcome completion date]
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.
Eligibility Criteria
Criteria
Major Inclusion Criteria:
-
Age >18 years
-
Histologically confirmed diagnosis of DLBCL
-
Tumour tissue for central pathology review and correlative studies must be provided.
-
Patients must have:
-
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 have included a CD20-targeted therapy
-
Eastern Cooperative Oncology Group 0 to 2
-
Patients not considered in the opinion of the investigator eligible, or patients unwilling to undergo intensive salvage therapy including ASCT
-
Patients must meet the following laboratory criteria at screening:
-
absolute neutrophil count ≥1.5 × 109/L
-
platelet count ≥90 × 109/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
-
agree to ongoing pregnancy testing
-
commit 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) must
-
use an effective barrier method of contraception
-
refrain from donating blood or sperm
- In the opinion of the investigator the patients must:
-
be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
-
be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.
Major Exclusion Criteria:
- Patients who have:
-
other histological type of lymphoma
-
primary refractory DLBCL
-
a history of "double/triple hit" genetics
- Patients who have, within 14 days prior to Day 1 dosing:
-
not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
-
undergone major surgery or suffered from significant traumatic injury
-
received live vaccines.
-
required parenteral antimicrobial therapy for active, intercurrent infections
- Patients who:
-
were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN)
-
have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
-
have undergone previous allogenic stem cell transplantation
-
have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
-
concurrently use other anticancer or experimental treatments
-
Prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥5 years prior to screening.
-
Patients 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 compromise the patient's ability to give informed consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | MorphoSys Research Site | Bakersfield | California | United States | 93309 |
2 | MorphoSys Research Site | Redondo Beach | California | United States | 90277 |
3 | MorphoSys Research Site | Santa Maria | California | United States | 93454 |
4 | MorphoSys Research Site | Grand Junction | Colorado | United States | 81501 |
5 | MorphoSys Research Site | Norwalk | Connecticut | United States | 06856 |
6 | MorphoSys Research Site | Michigan Center | Michigan | United States | 48179 |
7 | MorphoSys Research Site | Columbus | Ohio | United States | 43210 |
8 | MorphoSys Research Site | Charleston | South Carolina | United States | 29414 |
9 | MorphoSys Research Site | Tyler | Texas | United States | 75701 |
10 | MorphoSys Research Site | Antwerp | Belgium | 2020 | |
11 | MorphoSys Research Site | Kortrijk | Belgium | 8500 | |
12 | MorphoSys Research Site | Liege | Belgium | 4000 | |
13 | MorphoSys Research Site | Yvoir | Belgium | 5530 | |
14 | MorphoSys Research Site | Olomouc | Czechia | ||
15 | MorphoSys Research Site | Clermont-Ferrand | France | 63000 | |
16 | MorphoSys Research Site | Limoges | France | 87042 | |
17 | MorphoSys Research Site | Lyon | France | 69495 | |
18 | MorphoSys Research Site | Paris | France | 75015 | |
19 | MorphoSys Research Site | Essen | Germany | 45147 | |
20 | MorphoSys Research Site | Frankfurt | Germany | 60488 | |
21 | MorphoSys Research Site | Munich | Germany | ||
22 | MorphoSys Research Site | Nürnberg | Germany | 90419 | |
23 | MorphoSys Research Site | Würzburg | Germany | 97080 | |
24 | MorphoSys Research Site | Budapest | Hungary | 1122 | |
25 | MorphoSys Research Site | Budapest | Hungary | ||
26 | MorphoSys Research Site | Debrecen | Hungary | 4032 | |
27 | MorphoSys Research Site | Bari | Italy | 70124 | |
28 | MorphoSys Research Site | Bologna | Italy | ||
29 | MorphoSys Research Site | Firenze | Italy | 50134 | |
30 | MorphoSys Research Site | Modena | Italy | 41124 | |
31 | MorphoSys Research Site | Novara | Italy | 28100 | |
32 | MorphoSys Research Site | Perugia | Italy | 6132 | |
33 | MorphoSys Research Site | Roma | Italy | 133 | |
34 | MorphoSys Research Site | Terni | Italy | 5100 | |
35 | MorphoSys Research Site | Krakow | Poland | ||
36 | MorphoSys Research Site | Olsztyn | Poland | 10228 | |
37 | MorphoSys Research Site | Opole | Poland | 45061 | |
38 | MorphoSys Research Site | Poznan | Poland | 60631 | |
39 | MorphoSys Research Site | Rzeszow | Poland | 35055 | |
40 | MorphoSys Research Site | Warszawa | Poland | 02106 | |
41 | MorphoSys Research Site | Warszawa | Poland | 02781 | |
42 | MorphoSys Research Site | Barcelona | Spain | 8035 | |
43 | MorphoSys Research Site | Barcelona | Spain | 8908 | |
44 | MorphoSys Research Site | Barcelona | Spain | 8916 | |
45 | MorphoSys Research Site | Madrid | Spain | 28040 | |
46 | MorphoSys Research Site | Madrid | Spain | 28223 | |
47 | MorphoSys Research Site | Madrid | Spain | ||
48 | MorphoSys Research Site | Pamplona | Spain | 31008 | |
49 | MorphoSys Research Site | Sevilla | Spain | 41013 | |
50 | MorphoSys Research Site | Bournemouth | United Kingdom | BH77DW | |
51 | MorphoSys Research Site | Liverpool | United Kingdom | ||
52 | MorphoSys Research Site | London | United Kingdom | W1G 6AD | |
53 | MorphoSys Research Site | Newcastle | United Kingdom | NE7 7DN |
Sponsors and Collaborators
- MorphoSys AG
Investigators
- Study Director: Anna-Maria Jegg, PhD, Global Program Medical Director
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- MOR208C203
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Treatment (MOR00208, Lenalidomide) |
---|---|
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 |
NOT COMPLETED | 51 |
Baseline Characteristics
Arm/Group Title | Treatment (MOR00208, Lenalidomide) |
---|---|
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 Participants | 81 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
23
28.4%
|
>=65 years |
58
71.6%
|
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
69.3
(9.53)
|
Sex: Female, Male (Count of Participants) | |
Female |
37
45.7%
|
Male |
44
54.3%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
2
2.5%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
0
0%
|
White |
72
88.9%
|
More than one race |
0
0%
|
Unknown or Not Reported |
7
8.6%
|
Region of Enrollment (Count of 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%
|
United Kingdom |
5
6.2%
|
France |
9
11.1%
|
Germany |
11
13.6%
|
Spain |
15
18.5%
|
Outcome Measures
Title | Number of Participants With Best Objective Response Rate |
---|---|
Description | ORR = complete response [CR] + partial response [PR]; IRC Evaluation |
Time Frame | 1-3 years approximately |
Outcome Measure Data
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) |
---|---|
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 |
Measure Participants | 80 |
Count of Participants [Participants] |
48
59.3%
|
Title | Disease Control Rate (DCR) |
---|---|
Description | DCR = CR + PR + SD; IRC Evaluation |
Time Frame | 1-3 years approximately |
Outcome Measure Data
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) |
---|---|
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 |
Measure Participants | 80 |
Count of Participants [Participants] |
59
72.8%
|
Title | Duration of Response (DoR) |
---|---|
Description | IRC Evaluation |
Time Frame | 1-3 years approximately |
Outcome Measure Data
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) |
---|---|
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 |
Measure Participants | 80 |
Median (95% Confidence Interval) [months] |
21.7
|
Title | Progression-free Survival (PFS) |
---|---|
Description | IRC Evaluation |
Time Frame | 1-3 years approximately |
Outcome Measure Data
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) |
---|---|
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 |
Measure Participants | 80 |
Median (95% Confidence Interval) [months] |
12.1
|
Title | Percentage of Participants With Overall Survival (OS) |
---|---|
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 |
Outcome Measure Data
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) |
---|---|
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 |
Measure Participants | 80 |
Number [Percentage of partipants] |
74
|
Adverse Events
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 | ||
Arm/Group Title | Treatment (MOR00208, Lenalidomide) | |
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 (%) | # Events | |
Total | 30/81 (37%) | |
Serious Adverse Events |
||
Treatment (MOR00208, Lenalidomide) | ||
Affected / at Risk (%) | # Events | |
Total | 41/81 (50.6%) | |
Blood and lymphatic system disorders | ||
Febrile neutropenia | 5/81 (6.2%) | 5 |
Agranulocytosis | 1/81 (1.2%) | 2 |
Cardiac disorders | ||
Atrial fibrillation | 2/81 (2.5%) | 2 |
Cardiac failure congestive | 2/81 (2.5%) | 2 |
Cardiac failure | 1/81 (1.2%) | 1 |
Myocardial ischaemia | 1/81 (1.2%) | 1 |
Gastrointestinal disorders | ||
Diarrhoea | 1/81 (1.2%) | 1 |
General disorders | ||
Fatigue | 1/81 (1.2%) | 1 |
Pyrexia | 1/81 (1.2%) | 1 |
Sudden death | 1/81 (1.2%) | 1 |
Hepatobiliary disorders | ||
Biliary colic | 1/81 (1.2%) | 1 |
Infections and infestations | ||
Pneumonia | 5/81 (6.2%) | 5 |
Bronchitis | 2/81 (2.5%) | 2 |
Bronchopulmonary aspergillosis | 1/81 (1.2%) | 2 |
Cytomegalovirus infection | 1/81 (1.2%) | 1 |
Enterobacter bacteraemia | 1/81 (1.2%) | 1 |
Escherichia bacteraemia | 1/81 (1.2%) | 1 |
Febrile infection | 1/81 (1.2%) | 1 |
Influenza | 1/81 (1.2%) | 1 |
Klebsiella sepsis | 1/81 (1.2%) | 1 |
Lower respiratory tract infection | 1/81 (1.2%) | 3 |
Neutropenic sepsis | 1/81 (1.2%) | 1 |
Parainfluenzae virus infection | 1/81 (1.2%) | 1 |
Progressive multifocal leukoencephalopathy | 1/81 (1.2%) | 1 |
Respiratory syncytial virus infection | 1/81 (1.2%) | 1 |
Sepsis | 1/81 (1.2%) | 2 |
Soft tissue infection | 1/81 (1.2%) | 1 |
Streptococcal sepsis | 1/81 (1.2%) | 1 |
Urinary tract infection | 1/81 (1.2%) | 1 |
Urinary tract infection enterococcal | 1/81 (1.2%) | 1 |
Varicella zoster virus infection | 1/81 (1.2%) | 1 |
Injury, poisoning and procedural complications | ||
Femur fracture | 1/81 (1.2%) | 1 |
Lower limb fracture | 1/81 (1.2%) | 1 |
Wound complication | 1/81 (1.2%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Arthritis | 1/81 (1.2%) | 1 |
Muscular weakness | 1/81 (1.2%) | 1 |
Osteonecrosis | 1/81 (1.2%) | 1 |
Pathological fracture | 1/81 (1.2%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Squamous cell carcinoma | 1/81 (1.2%) | 1 |
Tumour flare | 1/81 (1.2%) | 1 |
Nervous system disorders | ||
Cerebrovascular accident | 1/81 (1.2%) | 1 |
Cervicobrachial syndrome | 1/81 (1.2%) | 1 |
Cognitive disorder | 1/81 (1.2%) | 1 |
Facial paralysis | 1/81 (1.2%) | 1 |
Sciatica | 1/81 (1.2%) | 1 |
Transient global amnesia | 1/81 (1.2%) | 1 |
Renal and urinary disorders | ||
Renal failure | 1/81 (1.2%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Pulmonary embolism | 3/81 (3.7%) | 3 |
Chronic obstructive pulmonary disease | 1/81 (1.2%) | 2 |
Dyspnoea | 1/81 (1.2%) | 1 |
Respiratory failure | 1/81 (1.2%) | 1 |
Vascular disorders | ||
Deep vein thrombosis | 1/81 (1.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Treatment (MOR00208, Lenalidomide) | ||
Affected / at Risk (%) | # Events | |
Total | 74/81 (91.4%) | |
Blood and lymphatic system disorders | ||
Any TEAE | 52/81 (64.2%) | 392 |
Neutropenia | 40/81 (49.4%) | 192 |
Anaemia | 28/81 (34.6%) | 59 |
Thrombocytopenia | 25/81 (30.9%) | 72 |
Leukopenia | 12/81 (14.8%) | 48 |
Febrile neutropenia | 5/81 (6.2%) | 6 |
Lymphopenia | 5/81 (6.2%) | 15 |
Gastrointestinal disorders | ||
Any TEAE | 45/81 (55.6%) | 111 |
Diarrhoea | 27/81 (33.3%) | 51 |
Constipation | 13/81 (16%) | 17 |
Nausea | 12/81 (14.8%) | 20 |
Vomiting | 11/81 (13.6%) | 14 |
Abdominal pain | 8/81 (9.9%) | 9 |
General disorders | ||
Any TEAE | 45/81 (55.6%) | 117 |
Asthenia | 19/81 (23.5%) | 31 |
Oedema peripheral | 18/81 (22.2%) | 30 |
Pyrexia | 16/81 (19.8%) | 27 |
Fatigue | 13/81 (16%) | 21 |
Mucosal inflammation | 6/81 (7.4%) | 8 |
Immune system disorders | ||
Any TEAE | 5/81 (6.2%) | 5 |
Hypogammaglobulinaemia | 5/81 (6.2%) | 5 |
Infections and infestations | ||
Any TEAE | 32/81 (39.5%) | 55 |
Bronchitis | 9/81 (11.1%) | 13 |
Nasopharyngitis | 8/81 (9.9%) | 9 |
Respiratory tract infection | 8/81 (9.9%) | 10 |
Upper respiratory tract infection | 8/81 (9.9%) | 9 |
Urinary tract infection | 6/81 (7.4%) | 9 |
Gastroenteritis | 5/81 (6.2%) | 5 |
Injury, poisoning and procedural complications | ||
Any TEAE | 5/81 (6.2%) | 5 |
Infusion related reaction | 5/81 (6.2%) | 5 |
Investigations | ||
Any TEAE | 15/81 (18.5%) | 35 |
C-reactive protein increased | 8/81 (9.9%) | 11 |
Blood creatinine increased | 7/81 (8.6%) | 17 |
Gamma-glutamyltransferase increased | 5/81 (6.2%) | 7 |
Metabolism and nutrition disorders | ||
Any TEAE | 31/81 (38.3%) | 76 |
Decreased appetite | 16/81 (19.8%) | 18 |
Hypokalaemia | 15/81 (18.5%) | 25 |
Hypomagnesaemia | 8/81 (9.9%) | 17 |
Hypocalcaemia | 5/81 (6.2%) | 16 |
Musculoskeletal and connective tissue disorders | ||
Any TEAE | 30/81 (37%) | 48 |
Back pain | 14/81 (17.3%) | 16 |
Muscle spasms | 12/81 (14.8%) | 16 |
Pain in extremity | 7/81 (8.6%) | 9 |
Arthralgia | 6/81 (7.4%) | 7 |
Nervous system disorders | ||
Any TEAE | 13/81 (16%) | 18 |
Headache | 7/81 (8.6%) | 12 |
Paraesthesia | 6/81 (7.4%) | 6 |
Psychiatric disorders | ||
Any TEAE | 6/81 (7.4%) | 8 |
Anxiety | 6/81 (7.4%) | 8 |
Respiratory, thoracic and mediastinal disorders | ||
Any TEAE | 25/81 (30.9%) | 44 |
Cough | 18/81 (22.2%) | 24 |
Dyspnoea | 10/81 (12.3%) | 15 |
Oropharyngeal pain | 5/81 (6.2%) | 5 |
Skin and subcutaneous tissue disorders | ||
Any TEAE | 14/81 (17.3%) | 17 |
Pruritus | 8/81 (9.9%) | 9 |
Rash | 6/81 (7.4%) | 8 |
Vascular disorders | ||
Any TEAE | 12/81 (14.8%) | 14 |
Hypertension | 7/81 (8.6%) | 9 |
Hypotension | 5/81 (6.2%) | 5 |
Limitations/Caveats
More Information
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
Name/Title | Dr. Sumeet Ambarkhane, Director, Clinical Program Leader |
---|---|
Organization | MorphoSys AG |
Phone | +49 89 89927 26841 |
Sumeet.Ambarkhane@morphosys.com |
- MOR208C203