NCT02514239 is a Phase 1 clinical trial of BI 836909 in Multiple Myeloma, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT02514239?

NCT02514239 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT02514239?

Interventions in NCT02514239: BI 836909.

What condition does NCT02514239 study?

NCT02514239 studies Multiple Myeloma.

Is NCT02514239 still recruiting?

NCT02514239 is currently completed. Last updated 24 February 2022.

Are results published for NCT02514239?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-02-24 · How we verify

NCT02514239

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Multiple Myeloma Patients

Completed Phase 1 Results posted Last updated 24 February 2022

What this trial tests

Phase 1 trial testing BI 836909 in Multiple Myeloma in 43 participants. Completed in 2 July 2020.

Timeline

8 July 2015

Primary endpoint
17 July 2018

2 July 2020

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	8 July 2015
Primary completion	17 July 2018
Estimated completion	2 July 2020
Sites	5 locations across France, Germany

Drugs / interventions tested

BI 836909 — full drug profile →

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 100, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Maximum Tolerated Dose (MTD) of BI 836909 Primary · Cycle 1, up to 6 weeks.

The Maximum tolerated dose (MTD) of BI 836909, which was defined as the highest dose of the dose level tested where ≤1 patient out of 6 developed a Dose-limiting toxicity (DLT). The MTD was defined based on DLTs observed during Cycle 1. However, all Adverse Events corresponding to the definition of a DLT (see below) were to be considered for confirming the MTD. A DLT was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.

Group	Value	95% CI
Intravenous Infusion of BI 836909 (Total Dose Escalation)	400

The Number of Patients With Dose-limiting Toxicities (DLTs) Primary · Cycle 1, up to 6 weeks.

The number of patients with Dose-limiting toxicities (DLTs) in cycle 1. A Dose-limiting toxicity was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.

Group	Value	95% CI
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	0
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	0
Intravenous Infusion of BI 836909 (100 μg/d)	0
Intravenous Infusion of BI 836909 (200 μg/d)	0
Intravenous Infusion of BI 836909 (400 μg/d)	1
Intravenous Infusion of BI 836909 (800 μg/d)	2

Number of Participants With an Objective Response Secondary · On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Extended follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.

Objective responses: Stringent complete response (sCR): CR + normal Free light chain (FLC) ratio and no clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Very good partial response (VGPR): serum and urine M protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M protein plus urine M protein level \<100 mg/24h. PR: \>50% reduction of serum and 24 h urinary M protein by \>90% or to \<200mg/24h. If unmeasur

On treatment

Group	Value	95% CI
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	0
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	0
Intravenous Infusion of BI 836909 (100 μg/d)	0
Intravenous Infusion of BI 836909 (200 μg/d)	1
Intravenous Infusion of BI 836909 (400 μg/d)	5
Intravenous Infusion of BI 836909 (800 μg/d)	0
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	1
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	0
Intravenous Infusion of BI 836909 (100 μg/d)	1
Intravenous Infusion of BI 836909 (200 μg/d)	0
Intravenous Infusion of BI 836909 (400 μg/d)	0
Intravenous Infusion of BI 836909 (800 μg/d)	0
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	0
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	0
Intravenous Infusion of BI 836909 (100 μg/d)	0
Intravenous Infusion of BI 836909 (200 μg/d)	0
Intravenous Infusion of BI 836909 (400 μg/d)	1
Intravenous Infusion of BI 836909 (800 μg/d)	1
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	0
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	1
Intravenous Infusion of BI 836909 (100 μg/d)	0
Intravenous Infusion of BI 836909 (200 μg/d)	0
Intravenous Infusion of BI 836909 (400 μg/d)	1
Intravenous Infusion of BI 836909 (800 μg/d)	1

On treatment + extended follow-up visits (follow-up

Group	Value	95% CI
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	0
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	0
Intravenous Infusion of BI 836909 (100 μg/d)	0
Intravenous Infusion of BI 836909 (200 μg/d)	1
Intravenous Infusion of BI 836909 (400 μg/d)	5
Intravenous Infusion of BI 836909 (800 μg/d)	0
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	1
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	0
Intravenous Infusion of BI 836909 (100 μg/d)	1
Intravenous Infusion of BI 836909 (200 μg/d)	0
Intravenous Infusion of BI 836909 (400 μg/d)	0
Intravenous Infusion of BI 836909 (800 μg/d)	1
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	0
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	0
Intravenous Infusion of BI 836909 (100 μg/d)	0
Intravenous Infusion of BI 836909 (200 μg/d)	0
Intravenous Infusion of BI 836909 (400 μg/d)	1
Intravenous Infusion of BI 836909 (800 μg/d)	1
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	0
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	1
Intravenous Infusion of BI 836909 (100 μg/d)	0
Intravenous Infusion of BI 836909 (200 μg/d)	0
Intravenous Infusion of BI 836909 (400 μg/d)	1
Intravenous Infusion of BI 836909 (800 μg/d)	0

Duration of Objective Response - on Treatment Secondary · From start of treatment till end of trial (EOT) visit, up to 61 weeks.

For patients with objective response, the duration of response was calculated from the time of first recorded achievement of a response (sCR, CR, PR, or VGPR) until documented progression or death. The Kaplan-Meier method was used to calculate the estimates.

Group	Value	95% CI
Intravenous Infusion of BI 836909 (6.5 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (50 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (100 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (200 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (400 μg/d)	NA	4.63 – NA
Intravenous Infusion of BI 836909 (800 μg/d)	NA	NA – NA

Duration of Objective Response - Including Extended Follow up Visits Secondary · From start of treatment till the last extended follow-up visit which is scheduled at 12 months after end of treatment, up to 113 weeks.

Group	Value	95% CI
Intravenous Infusion of BI 836909 (6.5 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (50 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (100 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (200 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (400 μg/d)	23.62	4.63 – 24.18
Intravenous Infusion of BI 836909 (800 μg/d)	NA	NA – NA

Number of Participants With a Minimal Residual Disease (MRD) Response Secondary · On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.

Minimal residual disease (MRD) response was defined as \<1 tumour cell within 10000 normal cells in bone marrow. MRD was determined using Fluorescence-activated cell sorting (FACS) analysis.

On treatment

Group	Value	95% CI
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	1
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	0
Intravenous Infusion of BI 836909 (100 μg/d)	0
Intravenous Infusion of BI 836909 (200 μg/d)	1
Intravenous Infusion of BI 836909 (400 μg/d)	6
Intravenous Infusion of BI 836909 (800 μg/d)	0

On treatment + extended follow-up visits (follow-up)

Group	Value	95% CI
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	0
Intravenous Infusion of BI 836909 (3.2 μg/d)	0
Intravenous Infusion of BI 836909 (6.5 μg/d)	1
Intravenous Infusion of BI 836909 (13 μg/d)	0
Intravenous Infusion of BI 836909 (25 μg/d)	0
Intravenous Infusion of BI 836909 (50 μg/d)	0
Intravenous Infusion of BI 836909 (100 μg/d)	0
Intravenous Infusion of BI 836909 (200 μg/d)	1
Intravenous Infusion of BI 836909 (400 μg/d)	6
Intravenous Infusion of BI 836909 (800 μg/d)	0

Duration of Minimal Residual Disease (MRD) Response - on Treatment Secondary · From start of treatment till end of trial (EOT) visit, up to 61 weeks.

Duration of MRD response was calculated from the time of first recorded achievement of a MRD response to documented progression or death. The Kaplan-Meier method was used to calculate the estimates.

Group	Value	95% CI
Intravenous Infusion of BI 836909 (6.5 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (200 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (400 μg/d)	NA	9.00 – NA

Duration of Minimal Residual Disease (MRD) Response - Including Extended Follow up Visits Secondary · From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.

Duration of MRD response was calculated from the time of first recorded achievement of a MRD response to documented progression or death. The Kaplan-Meier method was used to calculate the estimates.

Group	Value	95% CI
Intravenous Infusion of BI 836909 (6.5 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (200 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (400 μg/d)	20.70	9.00 – 22.77

Progression-free Survival (PFS) - on Treatment Secondary · From start of treatment till end of trial (EOT) visit, up to 61 weeks.

PFS was defined as time from first treatment with BI 836909 till disease progression or death. Progression was defined according to International Myeloma Working Group (IMWG 2006) response criteria as an increase \>25% from lowest response value in any of the following parameters: -Serum M protein (absolute increase had to be \>0.5 gram/ deciliters (dL)) -Urine M protein (absolute increase had to be \>200 milligram (mg)/24 hour) -Only in patients without measurable serum and urine M protein levels The difference between involved and uninvolved FLC levels. Absolute increase had to be \>10 mg/dL

Group	Value	95% CI
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (3.2 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (6.5 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (13 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (25 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (50 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (100 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (200 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (400 μg/d)	5.55	0.95 – NA
Intravenous Infusion of BI 836909 (800 μg/d)	NA	NA – NA

Progression-free Survival (PFS) - Including Extended Follow up Visits Secondary · From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.

Group	Value	95% CI
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (3.2 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (6.5 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (13 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (25 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (50 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (100 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (200 μg/d)	NA	NA – NA
Intravenous Infusion of BI 836909 (400 μg/d)	7.74	0.95 – 24.41
Intravenous Infusion of BI 836909 (800 μg/d)	NA	NA – NA

Serum Concentration at Steady State of BI 836909 (Css) Secondary · Pharmacokinetic samples were collected at 48:00 hours (h):minutes (min), 168:00, 336:00, 504:00 and 671:50 h after the start of infusion of BI 836909 of the first cycle.

Serum concentration at steady state of BI 836909 (Css).

Group	Value	95% CI
Intravenous Infusion of BI 836909 (0.2 μg/d)	NA	± NA
Intravenous Infusion of BI 836909 (0.4 μg/d)	86.5	± NA
Intravenous Infusion of BI 836909 (0.8 μg/d)	90.8	± 41.1
Intravenous Infusion of BI 836909 (1.6 μg/d)	184	± NA
Intravenous Infusion of BI 836909 (3.2 μg/d)	526	± 34.7
Intravenous Infusion of BI 836909 (6.5 μg/d)	1070	± 67.3
Intravenous Infusion of BI 836909 (13 μg/d)	2180	± 34.6
Intravenous Infusion of BI 836909 (25 μg/d)	4130	± 30.7
Intravenous Infusion of BI 836909 (50 μg/d)	10700	± 55.4
Intravenous Infusion of BI 836909 (100 μg/d)	9810	± 47.6
Intravenous Infusion of BI 836909 (200 μg/d)	14100	± 121
Intravenous Infusion of BI 836909 (400 μg/d)	29900	± 54.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intravenous Infusion of BI 836909 (0.2 μg/d)

Serious: 1/1 (100%)

Deaths: 0/1

Intravenous Infusion of BI 836909 (0.4 μg/d)

Serious: 0/1 (0%)

Deaths: 0/1

Intravenous Infusion of BI 836909 (0.8 μg/d)

Serious: 1/2 (50%)

Deaths: 0/2

Intravenous Infusion of BI 836909 (1.6 μg/d)

Serious: 0/1 (0%)

Deaths: 0/1

Intravenous Infusion of BI 836909 (3.2 μg/d)

Serious: 1/3 (33%)

Deaths: 0/3

Intravenous Infusion of BI 836909 (6.5 μg/d)

Serious: 3/3 (100%)

Deaths: 0/3

Intravenous Infusion of BI 836909 (13 μg/d)

Serious: 1/3 (33%)

Deaths: 0/3

Intravenous Infusion of BI 836909 (25 μg/d)

Serious: 1/3 (33%)

Deaths: 0/3

Intravenous Infusion of BI 836909 (50 μg/d)

Serious: 3/5 (60%)

Deaths: 1/5

Intravenous Infusion of BI 836909 (100 μg/d)

Serious: 2/4 (50%)

Deaths: 0/4

Intravenous Infusion of BI 836909 (200 μg/d)

Serious: 3/3 (100%)

Deaths: 0/3

Intravenous Infusion of BI 836909 (400 μg/d)

Serious: 8/10 (80%)

Deaths: 1/10

Intravenous Infusion of BI 836909 (800 μg/d)

Serious: 3/3 (100%)

Deaths: 0/3

Intravenous Infusion of BI 836909 (Total Dose Escalation)

Serious: 27/42 (64%)

Deaths: 2/42

Serious adverse events (23 terms)

Reaction	System	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…
Cytokine release syndrome	Immune system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vascular device infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Catheter site infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Disease progression	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Generalised oedema	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bile duct obstruction	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hepatic failure	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspergillus infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malnutrition	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Osteonecrosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Peripheral motor neuropathy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Polyneuropathy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Spinal cord compression	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Renal failure	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (150 terms — click to expand)

Reaction	System	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…	Intravenous Infusion of BI…
Lymphocyte count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cytokine release syndrome	Immune system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
C-reactive protein increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Staphylococcal infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood immunoglobulin G decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Cytokine release syndrome, Pneumonia, Vascular device infection, Catheter site infection, Device related infection, Influenza, Basal cell carcinoma, Cardiac failure.

Data from ClinicalTrials.gov NCT02514239 adverse events section.

Sponsor's own description

The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI 836909 administered by continuous i.v. infusion in patients with relapsed and/or refractory multiple myeloma. If the MTD is not reached based on safety findings, a recommended dose for further development will be determined. This will depend on the safety data, pharmacokinetic/pharmacodynamics data and potentially preliminary efficacy data. Secondary objectives are to document the safety and tolerability of BI 836909, to perform pharmacokinetic and pharmacodynamic analyses and to evaluate relevant biological effects in terms of parameters of efficacy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

B-cell maturation antigen (BCMA) in multiple myeloma: rationale for targeting and current therapeutic approaches.
Shah N, Chari A, Scott E, Mezzi K, et al · · 2020 · cited 347× · PMID 32055000 · DOI 10.1038/s41375-020-0734-z
Bispecific T cell engagers: an emerging therapy for management of hematologic malignancies.
Tian Z, Liu M, Zhang Y, Wang X. · · 2021 · cited 194× · PMID 33941237 · DOI 10.1186/s13045-021-01084-4
The landscape of bispecific T cell engager in cancer treatment.
Zhou S, Liu M, Ren F, Meng X, et al · · 2021 · cited 172× · PMID 34039409 · DOI 10.1186/s40364-021-00294-9
BCMA-targeted immunotherapy for multiple myeloma.
Yu B, Jiang T, Liu D. · · 2020 · cited 165× · PMID 32943087 · DOI 10.1186/s13045-020-00962-7
Immunogenic Cell Death and Immunotherapy of Multiple Myeloma.
Serrano-Del Valle A, Anel A, Naval J, Marzo I. · · 2019 · cited 152× · PMID 31041312 · DOI 10.3389/fcell.2019.00050
Monitoring, prophylaxis, and treatment of infections in patients with MM receiving bispecific antibody therapy: consensus recommendations from an expert panel.
Raje N, Anderson K, Einsele H, Efebera Y, et al · · 2023 · cited 120× · PMID 37528088 · DOI 10.1038/s41408-023-00879-7
T cell engaging bispecific antibody (T-BsAb): From technology to therapeutics.
Wu Z, Cheung NV. · · 2018 · cited 115× · PMID 28834699 · DOI 10.1016/j.pharmthera.2017.08.005
How to Train Your T Cells: Overcoming Immune Dysfunction in Multiple Myeloma.
Cohen AD, Raje N, Fowler JA, Mezzi K, et al · · 2020 · cited 90× · PMID 31672768 · DOI 10.1158/1078-0432.ccr-19-2111

Verify or expand the search:

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02514239 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 24 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02514239.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02514239

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (23 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Multiple Myeloma

Other Boehringer Ingelheim trials

Verify against primary sources