A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
Sponsor
MorphoSys AG (Industry)
Overall Status
Completed
CT.gov ID
NCT01421186
Collaborator
(none)
91
10
2
109
9.1
0.1
Study Details
Study Description
Brief Summary
This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects with relapsed/refractory multiple myeloma, as monotherapy and in adult subjects with relapsed/refractory multiple myeloma in combination with standard therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
The study enrolled patients aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher. Patients were assigned to the different treatment regimens with MOR202 ranging between 0·01 mg/kg and 16 mg/kg in a 3 + 3 design. Dose-escalation and expansion was done either with MOR202 intravenous infusions alone (MOR202 q2w [twice a week] and q1w [weekly] groups) or in combination with dexamethasone (MOR202 with dexamethasone group), with dexamethasone plus pomalidomide (MOR202 with dexamethasone plus pomalidomide group) or plus lenalidomide (MOR202 with dexamethasone plus lenalidomide group). Primary endpoints were safety, MOR202 maximum tolerated dose (or recommended dose) and regimen, and immunogenicity.
Study Design
Study Type:
Interventional
Actual Enrollment
:
91 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2a, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD 38 Antibody MOR03087 as Monotherapy and in Combination With Standard Therapy in Subjects With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date
:
Jul 1, 2011
Actual Primary Completion Date
:
Aug 1, 2020
Actual Study Completion Date
:
Aug 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Phase 1 dose escalation Part A: MOR03087 dose escalation; biweekly treatment Part B: MOR03087 dose escalation; weekly treatment Part C: MOR03087 dose escalation (weekly treatment) + dexamethasone Part D: MOR03087 weekly treatment in combination with pomalidomide + dexamethasone Part E: MOR03087 weekly treatment in combination with lenalidomide + dexamethasone For all parts, patients will be treated until disease progression (PD) or until a maximum of 3 years after first treatment. |
Drug: MOR03087 phase 1 dose escalation
Treatment cycles will be 28 days. Initial MOR03087 doses will be 0.01 mg/kg in part A, 4 mg/kg in parts B and C and 8 mg/kg in parts D and E; in all parts MOR03087 doses will be escalated to a maximum of 16 mg/kg. In part A, patients will receive a biweekly intravenous infusion of MOR03087 which will be administered on days 1 and 15 of the cycle. In parts B to E patients will receive a weekly intravenous infusion of MOR03087 which will be administered on days 1, 8, 15, and 22 of the cycle.
In all parts a loading dose of MOR03087 will be additionally administered on day 4 of cycle 1.
Drug: Dexamethasone
Dexamethasone will be administered to patients orally; 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on days 1, 8, 15, and 22 of the 28-day cycle. An additional dose will be administered in cycle 1 on day 4.
Drug: Pomalidomide
Pomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
Drug: Lenalidomide
Lenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
| Experimental: Phase 2a confirmatory cohorts Confirmatory cohorts of MOR03087 monotherapy (plus or minus dexamethasone), in combination with pomalidomide plus dexamethasone, and in combination with lenalidomide plus dexamethasone. Following completion of Parts A, B, and C (dose escalation of MOR03087 biweekly and weekly schedules), the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen will be confirmed in a minimum of 6 subjects. Following completion of Parts D (dose escalation of MOR03087 in combination with pomalidomide + dexamethasone) and E (dose escalation of MOR03087 in combination with lenalidomide + dexamethasone), the MTD and/or recommended dose in each part will be confirmed in a minimum of 6 subjects. For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment. |
Drug: MOR03087
MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E.
Drug: Dexamethasone
Dexamethasone will be administered to patients orally; 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on days 1, 8, 15, and 22 of the 28-day cycle. An additional dose will be administered in cycle 1 on day 4.
Drug: Pomalidomide
Pomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
Drug: Lenalidomide
Lenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
Outcome Measures
Primary Outcome Measures
- Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087 [First cycle of treatment]
as monotherapy in combination with dexamethasone in combination with pomalidomide + dexamethasone in combination with lenalidomide + dexamethasone
- Number of Participants Who Develop Anti-MOR03087 Antibodies [during treatment period, maximum 3 years after 1st dose]
Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity
Secondary Outcome Measures
- Overall Response Rate [maximum 3 years after 1st dose]
number (#) of patients responding (# stringent complete response + # complete response + # very good partial response + # partial response)
- Time to Progression [patients were observed for up to 36 months]
Time to Progression (Kaplan Meier estimate)
- Progression-free Survival [patients were observed up to 36 months]
Progression-free survival (Kaplan Meier estimates)
- Duration of Response [patients were observed up to 36 months]
Duration of response (Kaplan Meier estimates)
- Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202 [up to 7 days after last MOR202 dose]
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
- Pharmacokinetics: AUC Cycle 1+2 - Area Under the Time/Concentration Curve for MOR202 [56 days]
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female subjects 18 years and older
-
Relapsed or refractory multiple myeloma defined as:
Parts A, B and C:
(i) Failure of at least 2 previous therapies which must have included an immunomodulatory agent and a proteasome inhibitor (either together or part of different therapies) (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma
Part D:
(i) At least 2 previous therapies including lenalidomide and a proteasome inhibitor (ii) All subjects must have documented progression during or within 60 days after their last prior therapy for multiple myeloma
Part E:
(i) Received at least one previous therapy (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma
-
Presence of serum M-protein ≥ 0.5 g per 100 mL (≥ 5 g/L) and / or urine M-protein ≥ 200 mg per 24-hour period
-
Absolute neutrophil count (ANC) ≥ 1,000 / mm3
-
Haemoglobin ≥ 8 g/dL
-
Ability to comply with all study related procedures, medication use and evaluations
Exclusion Criteria:
-
Primary refractory multiple myeloma
-
History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher
-
Treatment with systemic investigational agent within 28 days prior to first study treatment
-
Solitary plasmacytoma or plasma cell leukaemia
-
Previous allogenic stem cell transplant (SCT)
-
Prior therapy with other monoclonal antibodies targeting the CD38 antigen or prior therapy with other IgG monoclonal antibodies within 3 months prior to first study treatment, or IgM monoclonal antibodies within 1 month prior to first study treatment
-
Active systemic infection
-
Systemic disease preventing study treatment
-
Multiple myeloma with central nervous system (CNS) involvement
-
Previous treatment with cytotoxic chemotherapy or large field radiotherapy or other myeloma specific therapy within 28 days prior to first study treatment (radiation to a single site as concurrent therapy is allowed)
-
Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] classes III, IV)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AKH (Allgemeines Krankenhaus der Stadt Wien), Abteilung für Klinische Onkologie, Universitätsklinik für Innere Medizin I | Vienna | Austria | 1090 | |
| 2 | Charité - Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin, CC 14: Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie | Berlin | Germany | 12200 | |
| 3 | Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus | Dresden | Germany | 01307 | |
| 4 | Medizinische Klinik 5 - Hämatologie und Internist. Onkologie, Universitätsklinikum Erlangen | Erlangen | Germany | 91054 | |
| 5 | Medizinische Universitätsklinik, Abt. Innere Medizin I | Freiburg | Germany | 79106 | |
| 6 | Universitäsklinikum Heidelberg, Klin.-Pharmakologisches Studienzentrum | Heidelberg | Germany | 69120 | |
| 7 | Sektion für Stammzell- und Immuntherapie, II. Medizinischen Klinik, | Kiel | Germany | 24105 | |
| 8 | Klinikum rechts der Isar/ Studien / III. Med. Klinik | Munich | Germany | 81675 | |
| 9 | Medizinische Klinik II, Abt. Hämatologie, Onkologie, | Tübingen | Germany | 7206 | |
| 10 | Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Studienambulanz für Hämatologie/Onkologie und Infektiologie | Würzburg | Germany | 97080 |
Sponsors and Collaborators
- MorphoSys AG
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
MorphoSys AG
ClinicalTrials.gov Identifier:
NCT01421186
Other Study ID Numbers:
- MOR202C101
- DRKS00003145
First Posted:
Aug 22, 2011
Last Update Posted:
Nov 16, 2021
Last Verified:
Jul 1, 2021
Keywords provided by MorphoSys AG
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg | Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old) | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle. | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle. |
| Period Title: Overall Study | |||||
| STARTED | 31 | 4 | 18 | 21 | 17 |
| COMPLETED | 31 | 4 | 18 | 21 | 17 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg | Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old) | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle. | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle. | Total of all reporting groups |
| Overall Participants | 31 | 4 | 18 | 21 | 17 | 91 |
| Age (Count of Participants) | ||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
8
25.8%
|
1
25%
|
7
38.9%
|
10
47.6%
|
8
47.1%
|
34
37.4%
|
| >=65 years |
23
74.2%
|
3
75%
|
11
61.1%
|
11
52.4%
|
9
52.9%
|
57
62.6%
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
12
38.7%
|
0
0%
|
8
44.4%
|
8
38.1%
|
5
29.4%
|
33
36.3%
|
| Male |
19
61.3%
|
4
100%
|
10
55.6%
|
13
61.9%
|
12
70.6%
|
58
63.7%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
31
100%
|
4
100%
|
18
100%
|
21
100%
|
17
100%
|
91
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||||
| Austria |
0
0%
|
0
0%
|
3
16.7%
|
1
4.8%
|
0
0%
|
4
4.4%
|
| Germany |
31
100%
|
4
100%
|
15
83.3%
|
20
95.2%
|
17
100%
|
87
95.6%
|
Outcome Measures
| Title | Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087 |
|---|---|
| Description | as monotherapy in combination with dexamethasone in combination with pomalidomide + dexamethasone in combination with lenalidomide + dexamethasone |
| Time Frame | First cycle of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg | Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old) | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle. | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle. |
| Measure Participants | 31 | 4 | 18 | 21 | 17 |
| Number [mg/kg] |
16
|
16
|
16
|
16
|
16
|
| Title | Number of Participants Who Develop Anti-MOR03087 Antibodies |
|---|---|
| Description | Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity |
| Time Frame | during treatment period, maximum 3 years after 1st dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| all patients with available data |
| Arm/Group Title | Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg | Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old) | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle. | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle. |
| Measure Participants | 31 | 4 | 18 | 21 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Overall Response Rate |
|---|---|
| Description | number (#) of patients responding (# stringent complete response + # complete response + # very good partial response + # partial response) |
| Time Frame | maximum 3 years after 1st dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg | Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old) | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle. | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle. |
| Measure Participants | 31 | 4 | 18 | 21 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
5
27.8%
|
10
47.6%
|
11
64.7%
|
| Title | Time to Progression |
|---|---|
| Description | Time to Progression (Kaplan Meier estimate) |
| Time Frame | patients were observed for up to 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| safety population |
| Arm/Group Title | Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg | Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old) | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle. | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle. |
| Measure Participants | 31 | 4 | 18 | 21 | 17 |
| Median (95% Confidence Interval) [months] |
1.1
|
2.1
|
8.4
|
15.9
|
33.2
|
| Title | Progression-free Survival |
|---|---|
| Description | Progression-free survival (Kaplan Meier estimates) |
| Time Frame | patients were observed up to 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg | Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old) | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle. | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle. |
| Measure Participants | 31 | 4 | 18 | 21 | 17 |
| Median (95% Confidence Interval) [months] |
1.1
|
2.1
|
8.4
|
15.9
|
26.7
|
| Title | Duration of Response |
|---|---|
| Description | Duration of response (Kaplan Meier estimates) |
| Time Frame | patients were observed up to 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the total 91 patients, 26 obtained a response: 5 in part C, 10 in part D and 11 in part E. Duration of response was calculated only in these patients. |
| Arm/Group Title | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone |
|---|---|---|---|
| Arm/Group Description | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old) | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle. | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle. |
| Measure Participants | 5 | 10 | 11 |
| Median (95% Confidence Interval) [months] |
16.7
|
21.2
|
32.2
|
| Title | Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202 |
|---|---|
| Description | PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups |
| Time Frame | up to 7 days after last MOR202 dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmakokinetics was analysed on all available data on patients receiving 4mg/kg weekly, 8mg/kg weekly and 16 mg/kg weekly irrespective in which part the patients were treated. |
| Arm/Group Title | 4 mg/kg QW | 8 mg/kg QW | 16 mg/kg QW |
|---|---|---|---|
| Arm/Group Description | Dosing at 4 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4) | Dosing at 8 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4) | Dosing at 16 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4) |
| Measure Participants | 4 | 14 | 39 |
| Mean (Standard Deviation) [µg/mL] |
137.86
(79.43)
|
311.67
(118.33)
|
681.53
(226.69)
|
| Title | Pharmacokinetics: AUC Cycle 1+2 - Area Under the Time/Concentration Curve for MOR202 |
|---|---|
| Description | PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups |
| Time Frame | 56 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmakokinetics was analysed on all available data on patients receiving 4mg/kg weekly, 8mg/kg weekly and 16 mg/kg weekly irrespective in which part the patients were treated. |
| Arm/Group Title | 4 mg/kg QW | 8 mg/kg QW | 16 mg/kg QW |
|---|---|---|---|
| Arm/Group Description | Dosing at 4 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4) | Dosing at 8 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4) | Dosing at 16 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4) |
| Measure Participants | 4 | 14 | 39 |
| Mean (Standard Deviation) [mg*days/L] |
3307.57
(2332.07)
|
7970.15
(4289.21)
|
18178.57
(8414.44)
|
Adverse Events
| Time Frame | during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | regular investigator assessment and laboratory testing | |||||||||
| Arm/Group Title | Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone | |||||
| Arm/Group Description | Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg | Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment. MOR03087: MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E.. | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old) | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle. | Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle. | |||||
All Cause Mortality |
||||||||||
| Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/31 (6.5%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 4/17 (23.5%) | |||||
Serious Adverse Events |
||||||||||
| Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/31 (41.9%) | 4/4 (100%) | 7/18 (38.9%) | 20/21 (95.2%) | 14/17 (82.4%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Lymphopenia | 2/31 (6.5%) | 2 | 0/4 (0%) | 2 | 0/18 (0%) | 2 | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 |
| Thrombocytopenia | 0/31 (0%) | 1/4 (25%) | 2 | 0/18 (0%) | 2 | 1/21 (4.8%) | 2 | 0/17 (0%) | 2 | |
| Febrile Neutropenia | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Anaemia | 0/31 (0%) | 0/4 (0%) | 1/18 (5.6%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 | ||
| Leukopenia | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Cardiac disorders | ||||||||||
| Atrial Fibrillation | 0/31 (0%) | 1/4 (25%) | 3 | 0/18 (0%) | 0 | 1/21 (4.8%) | 2 | 0/17 (0%) | 0 | |
| Atrial Flutter | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Cardiac Failure | 1/31 (3.2%) | 1 | 0/4 (0%) | 1 | 0/18 (0%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 |
| Cardiovascular Disorder | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 | |||
| Myocardial Infarction | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Pericarditis | 0/31 (0%) | 1/4 (25%) | 1 | 0/18 (0%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 | |
| Sinus Tachycardia | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Gastrointestinal disorders | ||||||||||
| Dental Caries | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0 | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 | ||
| Mouth Haemorrhage | 0/31 (0%) | 0/4 (0%) | 1/18 (5.6%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 | ||
| Nausea | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Vomiting | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| General disorders | ||||||||||
| Pyrexia | 0/31 (0%) | 0/4 (0%) | 1/18 (5.6%) | 1 | 2/21 (9.5%) | 2 | 0/17 (0%) | 2 | ||
| Cheast Pain | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Infections and infestations | ||||||||||
| Pneumonia | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 6/21 (28.6%) | 9 | 1/17 (5.9%) | 1 |
| Respiratory tract infection | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 3/21 (14.3%) | 3 | 0/17 (0%) | 3 | |||
| Bronchitis | 0/31 (0%) | 0/4 (0%) | 2/18 (11.1%) | 2 | 0/21 (0%) | 2 | 0/17 (0%) | 2 | ||
| Pneumonia influenzal | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 | |||
| Pulmonary Sepsis | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 | |||
| Skin Infection | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 | |||
| Infectious Pleural Effusion | 0/31 (0%) | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |
| Bacterial Infection | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Erysipelas | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Influenza | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Meningoencephalitis Bacterial | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Parainfluenza Virus Infection | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Infection | 0/31 (0%) | 1/4 (25%) | 1 | 0/18 (0%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 | |
| Sinusitis | 0/31 (0%) | 0/4 (0%) | 1/18 (5.6%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 | ||
| Upper Respiratory Tract Infection | 1/31 (3.2%) | 1 | 0/4 (0%) | 1 | 0/18 (0%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 |
| Respiratory Syncytal Virus Infection | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Varicella Zoster Virus Infection | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Injury, poisoning and procedural complications | ||||||||||
| Infusion-related reaction | 4/31 (12.9%) | 4 | 4/4 (100%) | 4 | 0/18 (0%) | 4 | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 |
| Concussion | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Fall | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Femoral Neck Fracture | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 2 | 0/17 (0%) | 2 | |||
| Sternal Fracture | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 | ||
| Type 2 Diabetes Mellitus | 0/31 (0%) | 0/4 (0%) | 1/18 (5.6%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 | ||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Back Pain | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Osteonecrosis of Jaw | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Pseudarthrosis | 0/31 (0%) | 0/4 (0%) | 1/18 (5.6%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 | ||
| Spinal Stenosis | 1/31 (3.2%) | 1 | 0/4 (0%) | 1 | 0/18 (0%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Plasma Cell Myeloma | 4/31 (12.9%) | 4 | 0/4 (0%) | 4 | 0/18 (0%) | 4 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Breast Cancer | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 | |||
| Basal Cell Carcinoma | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Eccrine Carcinoma | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Malignant Melanoma | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 2 | 0/17 (0%) | 2 | |||
| Pancreatic Carcinoma | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Squamous Cell Carcinoma of the Skin | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 2 | 0/17 (0%) | 2 | |||
| Nervous system disorders | ||||||||||
| Radiculopathy | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 | ||
| Spinal Cord Compression | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Transient Ischaemic Attack | 0/31 (0%) | 0/4 (0%) | 1/18 (5.6%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 | ||
| Renal and urinary disorders | ||||||||||
| Acute Kidney Injury | 2/31 (6.5%) | 2 | 0/4 (0%) | 2 | 0/18 (0%) | 2 | 0/21 (0%) | 2 | 0/17 (0%) | 2 |
| Renal Failure | 1/31 (3.2%) | 1 | 0/4 (0%) | 1 | 0/18 (0%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 |
| Renal Impairment | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Dyspnoea | 0/31 (0%) | 0/4 (0%) | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 | ||
| Pneumonitis | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 1/21 (4.8%) | 1 | 0/17 (0%) | 1 | |||
| Pulmonary Embolism | 0/31 (0%) | 0/4 (0%) | 0/18 (0%) | 0/21 (0%) | 1/17 (5.9%) | 1 | ||||
| Vascular disorders | ||||||||||
| Thrombosis | 0/31 (0%) | 0/4 (0%) | 1/18 (5.6%) | 1 | 0/21 (0%) | 1 | 0/17 (0%) | 1 | ||
Other (Not Including Serious) Adverse Events |
||||||||||
| Part A: MOR03087 Biweekly Dose Escalation | Part B: MOR03087 Weekly Dose Escalation | Part C: MOR03087 Plus Dexamethasone | Part D: MOR03087 Plus Pomalidomide + Dexamethasone | Part E: MOR03087 Plus Lenalidomide + Dexamethasone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 31/31 (100%) | 4/4 (100%) | 18/18 (100%) | 21/21 (100%) | 17/17 (100%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Leukopenia | 8/31 (25.8%) | 13 | 4/4 (100%) | 7 | 8/18 (44.4%) | 28 | 17/21 (81%) | 91 | 15/17 (88.2%) | 55 |
| Neutropenia | 4/31 (12.9%) | 4 | 3/4 (75%) | 12 | 8/18 (44.4%) | 26 | 19/21 (90.5%) | 113 | 12/17 (70.6%) | 49 |
| Lymphopenia | 5/31 (16.1%) | 9 | 2/4 (50%) | 4 | 8/18 (44.4%) | 25 | 14/21 (66.7%) | 43 | 13/17 (76.5%) | 33 |
| Anaemia | 13/31 (41.9%) | 20 | 1/4 (25%) | 3 | 7/18 (38.9%) | 10 | 11/21 (52.4%) | 34 | 6/17 (35.3%) | 16 |
| Thrombocytopenia | 3/31 (9.7%) | 3 | 1/4 (25%) | 1 | 6/18 (33.3%) | 9 | 14/21 (66.7%) | 51 | 11/17 (64.7%) | 24 |
| Blood urea increased | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 2/17 (11.8%) | 2 |
| Neutrophilia | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Leukocytosis | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Cardiac disorders | ||||||||||
| Tachycardia | 3/31 (9.7%) | 3 | 2/4 (50%) | 3 | 3/18 (16.7%) | 3 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Angina pectoris | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 0/21 (0%) | 0 | 1/17 (5.9%) | 2 |
| Palpitations | 0/31 (0%) | 0 | 1/4 (25%) | 1 | 0/18 (0%) | 0 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Pericardial effusion | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Supraventricular extrasystoles | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Ear and labyrinth disorders | ||||||||||
| Vertigo | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 1/21 (4.8%) | 1 | 4/17 (23.5%) | 6 |
| Tinnitus | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Hypoacusis | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Eye disorders | ||||||||||
| Cataract | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 3/17 (17.6%) | 3 |
| Conjunctival haemorrhage | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 3/21 (14.3%) | 4 | 1/17 (5.9%) | 1 |
| Vision blurred | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Visual impairment | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Conjunctivitis allergic | 0/31 (0%) | 0 | 1/4 (25%) | 1 | 0/18 (0%) | 0 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Diplopia | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||
| Diarrhea | 7/31 (22.6%) | 9 | 1/4 (25%) | 1 | 4/18 (22.2%) | 5 | 11/21 (52.4%) | 15 | 10/17 (58.8%) | 26 |
| Constipation | 4/31 (12.9%) | 5 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 5/21 (23.8%) | 8 | 11/17 (64.7%) | 13 |
| Abdominal pain | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 2/18 (11.1%) | 2 | 2/21 (9.5%) | 4 | 3/17 (17.6%) | 4 |
| Nausea | 10/31 (32.3%) | 14 | 0/4 (0%) | 0 | 2/18 (11.1%) | 3 | 2/21 (9.5%) | 10 | 6/17 (35.3%) | 8 |
| Dyspepsia | 0/31 (0%) | 0 | 1/4 (25%) | 1 | 0/18 (0%) | 0 | 3/21 (14.3%) | 3 | 4/17 (23.5%) | 5 |
| Vomiting | 4/31 (12.9%) | 6 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 2/21 (9.5%) | 7 | 1/17 (5.9%) | 1 |
| Aphthous ulcer | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 2 | 4/21 (19%) | 5 | 1/17 (5.9%) | 2 |
| Dry mouth | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 2/21 (9.5%) | 4 | 2/17 (11.8%) | 2 |
| Stomatitis | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 2/21 (9.5%) | 2 | 1/17 (5.9%) | 1 |
| Toothache | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 2/21 (9.5%) | 2 | 0/17 (0%) | 0 |
| General disorders | ||||||||||
| Fatigue | 11/31 (35.5%) | 12 | 0/4 (0%) | 0 | 6/18 (33.3%) | 14 | 12/21 (57.1%) | 22 | 6/17 (35.3%) | 9 |
| Pyrexia | 5/31 (16.1%) | 6 | 0/4 (0%) | 0 | 3/18 (16.7%) | 4 | 5/21 (23.8%) | 7 | 2/17 (11.8%) | 3 |
| Disease progression | 1/31 (3.2%) | 1 | 1/4 (25%) | 1 | 2/18 (11.1%) | 2 | 5/21 (23.8%) | 5 | 3/17 (17.6%) | 3 |
| Oedema peripheral | 3/31 (9.7%) | 4 | 0/4 (0%) | 0 | 2/18 (11.1%) | 8 | 2/21 (9.5%) | 3 | 4/17 (23.5%) | 5 |
| Asthenia | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 3/18 (16.7%) | 3 | 2/21 (9.5%) | 2 | 1/17 (5.9%) | 1 |
| Pain | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Swelling | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 2/18 (11.1%) | 2 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Impaired healing | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Infections and infestations | ||||||||||
| Nasopharyngitis | 6/31 (19.4%) | 8 | 1/4 (25%) | 1 | 9/18 (50%) | 12 | 4/21 (19%) | 12 | 6/17 (35.3%) | 10 |
| Upper respiratory tract infection | 3/31 (9.7%) | 3 | 1/4 (25%) | 1 | 6/18 (33.3%) | 7 | 5/21 (23.8%) | 10 | 6/17 (35.3%) | 10 |
| Respiratory tract infection | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 2/18 (11.1%) | 12 | 8/21 (38.1%) | 18 | 4/17 (23.5%) | 8 |
| Pneumonia | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 4/21 (19%) | 5 | 2/17 (11.8%) | 2 |
| Bronchitis | 4/31 (12.9%) | 5 | 0/4 (0%) | 0 | 2/18 (11.1%) | 3 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Urinary tract infection | 1/31 (3.2%) | 1 | 1/4 (25%) | 3 | 3/18 (16.7%) | 3 | 2/21 (9.5%) | 3 | 2/17 (11.8%) | 3 |
| Infection | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 4/21 (19%) | 6 | 1/17 (5.9%) | 1 |
| Rhinitis | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 1/18 (5.6%) | 3 | 3/21 (14.3%) | 3 | 1/17 (5.9%) | 1 |
| Oral herpes | 1/31 (3.2%) | 2 | 0/4 (0%) | 0 | 2/18 (11.1%) | 2 | 2/21 (9.5%) | 2 | 1/17 (5.9%) | 1 |
| Herpes simplex | 0/31 (0%) | 0 | 1/4 (25%) | 1 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||
| Infusion related reaction | 6/31 (19.4%) | 8 | 1/4 (25%) | 1 | 3/18 (16.7%) | 4 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Arthropod sting | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 |
| Fall | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Limb injury | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 |
| Fracture | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Investigations | ||||||||||
| C-reactive proteine increased | 0/31 (0%) | 0 | 1/4 (25%) | 2 | 3/18 (16.7%) | 8 | 3/21 (14.3%) | 10 | 3/17 (17.6%) | 3 |
| Alanine aminotransferase increased | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 4/21 (19%) | 4 | 4/17 (23.5%) | 6 |
| Blood lactate dehydrogenase increased | 3/31 (9.7%) | 3 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 2/21 (9.5%) | 2 | 0/17 (0%) | 0 |
| Gamma-glutamyltransferase increased | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 2/21 (9.5%) | 3 | 4/17 (23.5%) | 6 |
| Lipase increased | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 3/18 (16.7%) | 14 | 0/21 (0%) | 0 | 3/17 (17.6%) | 3 |
| Amylase increased | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 2/18 (11.1%) | 5 | 2/21 (9.5%) | 2 | 0/17 (0%) | 0 |
| Aspartate aminotransferase increased | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 3/21 (14.3%) | 5 | 1/17 (5.9%) | 1 |
| Blood creatinine phosphokinase increased | 2/31 (6.5%) | 4 | 0/4 (0%) | 0 | 1/18 (5.6%) | 2 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Blood creatinine increased | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 2/18 (11.1%) | 10 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Metabolism and nutrition disorders | ||||||||||
| Hypokalaemia | 5/31 (16.1%) | 7 | 1/4 (25%) | 1 | 2/18 (11.1%) | 2 | 6/21 (28.6%) | 11 | 6/17 (35.3%) | 7 |
| Decreased appetite | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 2 | 2/21 (9.5%) | 3 | 3/17 (17.6%) | 3 |
| Hypocalcaemia | 0/31 (0%) | 0 | 1/4 (25%) | 1 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 5/17 (29.4%) | 5 |
| Hypophosphataemia | 3/31 (9.7%) | 4 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 2/17 (11.8%) | 7 |
| Iron deficiency | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 2/18 (11.1%) | 2 | 3/21 (14.3%) | 3 | 2/17 (11.8%) | 2 |
| Hyperglycaemia | 0/31 (0%) | 0 | 1/4 (25%) | 4 | 2/18 (11.1%) | 3 | 0/21 (0%) | 0 | 2/17 (11.8%) | 2 |
| Hyperuricaemia | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 2/18 (11.1%) | 2 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Hyperphosphataemia | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Hyponatraemia | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Gout | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Hyperamylasaemia | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Increased appetite | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Vitamin D Deficiency | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||
| Muscle spasm | 3/31 (9.7%) | 3 | 0/4 (0%) | 0 | 2/18 (11.1%) | 5 | 5/21 (23.8%) | 9 | 9/17 (52.9%) | 12 |
| Back pain | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 6/18 (33.3%) | 7 | 7/21 (33.3%) | 9 | 3/17 (17.6%) | 4 |
| Myalgia | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 3/18 (16.7%) | 4 | 4/21 (19%) | 6 | 2/17 (11.8%) | 2 |
| Pain in extremity | 3/31 (9.7%) | 3 | 0/4 (0%) | 0 | 4/18 (22.2%) | 5 | 1/21 (4.8%) | 1 | 2/17 (11.8%) | 2 |
| Bone pain | 3/31 (9.7%) | 4 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 4/21 (19%) | 5 | 1/17 (5.9%) | 1 |
| Musculoskeletal chest pain | 5/31 (16.1%) | 5 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 |
| Neck pain | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 2/21 (9.5%) | 2 | 3/17 (17.6%) | 3 |
| Musculoskeletal pain | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 3/18 (16.7%) | 3 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Flank pain | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 2/18 (11.1%) | 2 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Muscular weakness | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 2/21 (9.5%) | 2 | 0/17 (0%) | 0 |
| Spinal stenosis | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Bursitis | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Osteitis | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Plasma cell myeloma | 16/31 (51.6%) | 16 | 2/4 (50%) | 2 | 12/18 (66.7%) | 12 | 9/21 (42.9%) | 9 | 3/17 (17.6%) | 3 |
| Nervous system disorders | ||||||||||
| Headache | 6/31 (19.4%) | 8 | 0/4 (0%) | 0 | 6/18 (33.3%) | 8 | 2/21 (9.5%) | 2 | 1/17 (5.9%) | 1 |
| Dizziness | 3/31 (9.7%) | 4 | 0/4 (0%) | 0 | 3/18 (16.7%) | 5 | 1/21 (4.8%) | 1 | 5/17 (29.4%) | 6 |
| Paraesthesia | 2/31 (6.5%) | 3 | 1/4 (25%) | 1 | 1/18 (5.6%) | 1 | 4/21 (19%) | 4 | 0/17 (0%) | 0 |
| Dysaesthesia | 1/31 (3.2%) | 1 | 1/4 (25%) | 1 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Polyneuropathy | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 2 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Peripheral sensory neuropathy | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 3 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Dizziness postural | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 2 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Neuropathy peripheral | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 4 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Somnolence | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 3 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Psychiatric disorders | ||||||||||
| Insomnia | 1/31 (3.2%) | 1 | 1/4 (25%) | 1 | 6/18 (33.3%) | 21 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Confusional state | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 2/21 (9.5%) | 2 | 0/17 (0%) | 0 |
| Agitation | 0/31 (0%) | 0 | 1/4 (25%) | 1 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Sleep disorder | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 2 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Mood altered | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 2/21 (9.5%) | 2 | 0/17 (0%) | 0 |
| Renal and urinary disorders | ||||||||||
| Chronic kidney disease | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 1/21 (4.8%) | 1 | 2/17 (11.8%) | 2 |
| Renal failure | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||
| Pelvic pain | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 1/21 (4.8%) | 2 | 1/17 (5.9%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 3/31 (9.7%) | 3 | 2/4 (50%) | 3 | 3/18 (16.7%) | 3 | 5/21 (23.8%) | 8 | 5/17 (29.4%) | 6 |
| Dyspnoea | 4/31 (12.9%) | 4 | 0/4 (0%) | 0 | 3/18 (16.7%) | 3 | 1/21 (4.8%) | 1 | 1/17 (5.9%) | 1 |
| Oropharyngeal pain | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 2/21 (9.5%) | 2 | 3/17 (17.6%) | 8 |
| Epistaxis | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 2 | 2/21 (9.5%) | 2 | 1/17 (5.9%) | 1 |
| Dyspnoea exertional | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 1/18 (5.6%) | 2 | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 |
| Nasal congestion | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 1/17 (5.9%) | 1 |
| Rhinorrhoea | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Throat irritation | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 |
| Asthma | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 2 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||
| Rash | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 2/18 (11.1%) | 3 | 5/21 (23.8%) | 13 | 5/17 (29.4%) | 6 |
| Pruritus | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 1/18 (5.6%) | 2 | 3/21 (14.3%) | 5 | 2/17 (11.8%) | 2 |
| Night sweats | 3/31 (9.7%) | 3 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 3/17 (17.6%) | 6 |
| Hyperhidrosis | 3/31 (9.7%) | 4 | 0/4 (0%) | 0 | 0/18 (0%) | 0 | 3/21 (14.3%) | 3 | 0/17 (0%) | 0 |
| Erythema | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 2/21 (9.5%) | 2 | 1/17 (5.9%) | 1 |
| Petechiae | 1/31 (3.2%) | 1 | 0/4 (0%) | 0 | 3/18 (16.7%) | 3 | 1/21 (4.8%) | 1 | 0/17 (0%) | 0 |
| Acne | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Eczema asteatotic | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Nail growth abnormal | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Papule | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Rash papular | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Vascular disorders | ||||||||||
| Hypertension | 4/31 (12.9%) | 4 | 0/4 (0%) | 0 | 3/18 (16.7%) | 9 | 5/21 (23.8%) | 5 | 2/17 (11.8%) | 4 |
| Haematoma | 2/31 (6.5%) | 2 | 0/4 (0%) | 0 | 3/18 (16.7%) | 9 | 3/21 (14.3%) | 6 | 3/17 (17.6%) | 4 |
| Hypotension | 3/31 (9.7%) | 3 | 0/4 (0%) | 0 | 2/18 (11.1%) | 3 | 1/21 (4.8%) | 1 | 3/17 (17.6%) | 4 |
| Hot flush | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Iliac artery stenosis | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Varicous vein | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Restlessness | 0/31 (0%) | 0 | 0/4 (0%) | 0 | 1/18 (5.6%) | 1 | 3/21 (14.3%) | 3 | 0/17 (0%) | 0 |
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 Winrich Rauschning, Clinical Project Lead (external) |
|---|---|
| Organization | MorphoSys AG |
| Phone | +4989 89927 ext 0 |
| winrich.rauschning@external.morphosys.com |
Responsible Party:
MorphoSys AG
ClinicalTrials.gov Identifier:
NCT01421186
Other Study ID Numbers:
- MOR202C101
- DRKS00003145
First Posted:
Aug 22, 2011
Last Update Posted:
Nov 16, 2021
Last Verified:
Jul 1, 2021