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

Sponsor
MorphoSys AG (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02399085
Collaborator
(none)
81
53
1
80
1.5
0

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

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Nov 1, 2018
Anticipated Study Completion Date :
Nov 1, 2022

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:
  • MOR208
  • Drug: Lenalidomide
    25 mg
    Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Best Objective Response Rate [1-3 years approximately]

      ORR = complete response [CR] + partial response [PR]; IRC Evaluation

    Secondary Outcome Measures

    1. Disease Control Rate (DCR) [1-3 years approximately]

      DCR = CR + PR + SD; IRC Evaluation

    2. Duration of Response (DoR) [1-3 years approximately]

      IRC Evaluation

    3. Progression-free Survival (PFS) [1-3 years approximately]

      IRC Evaluation

    4. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Major Inclusion Criteria:
    1. Age >18 years

    2. Histologically confirmed diagnosis of DLBCL

    3. Tumour tissue for central pathology review and correlative studies must be provided.

    4. 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

    1. Patients not considered in the opinion of the investigator eligible, or patients unwilling to undergo intensive salvage therapy including ASCT

    2. 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

    1. 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

    1. Males (if sexually active with a FCBP) must
    • use an effective barrier method of contraception

    • refrain from donating blood or sperm

    1. 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:
    1. Patients who have:
    • other histological type of lymphoma

    • primary refractory DLBCL

    • a history of "double/triple hit" genetics

    1. 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

    1. 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

    1. Prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥5 years prior to screening.

    2. 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.
    Responsible Party:
    MorphoSys AG
    ClinicalTrials.gov Identifier:
    NCT02399085
    Other Study ID Numbers:
    • MOR208C203
    First Posted:
    Mar 26, 2015
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Keywords provided by MorphoSys AG
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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%
    2. Secondary Outcome
    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%
    3. Secondary Outcome
    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
    4. Secondary Outcome
    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
    5. Secondary Outcome
    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

    [Not Specified]

    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
    Email Sumeet.Ambarkhane@morphosys.com
    Responsible Party:
    MorphoSys AG
    ClinicalTrials.gov Identifier:
    NCT02399085
    Other Study ID Numbers:
    • MOR208C203
    First Posted:
    Mar 26, 2015
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021