Multiple MyelomaPhase 1NCT02514239
Phase I Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Multiple Myeloma Patients
A Phase 1 study testing BI 836909 in people with Multiple Myeloma, run by Boehringer Ingelheim at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BI 836909
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 8 Jul 2015to 2 Jul 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a documented diagnosis of relapsed and/or refractory multiple myeloma who progressed after at least two prior treatment regimens, including both proteasome inhibitor as well as an immune-modulatory drug at time of screening
- must have measurable disease, defined by one or more of following at time of screening:
- a serum M protein > 0.5 g/dl measured by serum protein electrophoresis
- urinary M protein excretion > 200 mg/24 hours
- serum free light chain (FLC) measurement > 10 mg/dl, provided that the serum FLC ratio is abnormal
- Relapse or progression of disease with an indication for therapy as per investigator´s judgement at time of screening
Show all 11Show fewer
- ECOG Performance Status 0, 1 or 2 at time of screening
- Age >= 18 years at time of screening
- Written informed consent which is consistent with ICH_GCP guidelines and local legislation
- Able to adhere to the study visit schedule e.g. ability to come to the clinic and to other protocol requirements
- Indwelling central venous catheter or willingness to undergo intra venous central line placement.
Who cannot join
- Plasma cell leukemia
- Extramedullary relapse of multiple myeloma
- Known central nervous system involvement by multiple myeloma
- Last anticancer treatment < 2 weeks prior to visit 1
- Last treatment with a therapeutic antibody less than 6 weeks prior to visit 1
- Prior allogeneic stem cell transplantation or solid organ transplantation
Show all 25Show fewer
- Autologous bone marrow transplantation < than 90 days at time of treatment start
- Last corticosteroid < 2 weeks prior to visit 1 unless the dose is <= 10 mg/day prednisolone or equivalent
- AST or ALT > 3 x upper limit of normal (CTCAE version 4.03 grade 2 or higher) at time of screening
- Total conjugated bilirubin > 1.5 x upper limit of normal (CTCAE version 4.03 grade 2 or higher) at time of screening
- Absolute neutrophil count < 1.0 x 109/L (without growth factor support) at time of screening
- Platelets < 25 x 109/L (without transfusions) at time of screening
- Calculated GFR < 30 mL/min (Cockcroft-Gault Formula) at time of screening
- Clinical relevant concurrent medical disease or condition which according to the investigator's judgement would either compromise patient safety or interfere with the evaluation of the safety of the test drug, e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia requiring therapy at time of screening
- clinically not controlled chronic or ongoing infectious disease requiring treatment at the time of enrolment or within the previous two weeks
- Active hepatitis B or C, or laboratory evidence for a chronic infection with hepatitis B or C at time of screening; HIV infection at time of screening
- Women of childbearing potential not using highly effective method of birth control during the trial until one year after the last dose. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year)when used consistently and correctly used such as implants, injectables, combined oral contraceptives, intrauterine devises (IUDs), sexual abstinence or vasectomised partner. Barrier methods of contraception are accepted if condom or occlusive cap is used together with spermicides (e.g. foam, gel). Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or postmenopausal (12 months with no menses without an alternative medical cause
- Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of 6 months after treatment
- Pregnancy or breast feeding
- Known or suspected active alcohol or drug abuse as per investigator's judgement
- Treatment with another investigational drug within the past four weeks before start of therapy or concomitantly with this trial
- Patients with known hypersensitivity to any component of the study drug
- Patients with other malignancies within 5 years at time of screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy)
- Known autoimmune diseases requiring systemic treatment in past 5 years and interfering with evaluation of study drug
- Pre-existing disorders of the central nervous system
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France3 sites
HOP Claude Huriez
Lille, 59037
HOP Hôtel-Dieu
Nantes, 44000
INS Universitaire du Cancer
Toulouse, 31059
Germany2 sites
Universitätsklinikum Ulm
Ulm, 89081
Universitätsklinikum Würzburg
Würzburg, 97080
About this study
Official title: An Open Label, Phase I, Dose Escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Doses of BI 836909 in Relapsed and/or Refractory Multiple Myeloma Patients
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.
- Conditions
- Multiple Myeloma
- Being tested
- BI 836909
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 836909Drug
Also called AMG 420
Intravenous Infusion of BI 836909.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Infusion of BI 836909 (0.2 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (0.4 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (0.8 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (1.6 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (13 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (25 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (50 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (100 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (200 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (400 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (800 μg/d) | Experimental | Not described Receives: Drug: BI 836909 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maximum Tolerated Dose (MTD) of BI 836909
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.
Measured: Cycle 1, up to 6 weeks.
The Number of Patients With Dose-limiting Toxicities (DLTs)
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.
Measured: Cycle 1, up to 6 weeks.
Secondary outcomes (9)
Number of Participants With an Objective Response
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 unmeasurable, a >50% decrease in difference between involved and uninvolved FLC levels instead of M protein criteria. if FLC assay was not measurable, a >50% reduction in plasma cells was required instead of M protein, provided baseline bone marrow plasma cell was >30%. In addition to the listed criteria, a >50% reduction in the size of soft tissue plasmacytomas was also required, if present at baseline.
Measured: 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.
Duration of Objective Response - on Treatment
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.
Measured: From start of treatment till end of trial (EOT) visit, up to 61 weeks.
Duration of Objective Response - Including Extended Follow up Visits
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.
Measured: 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.
Number of Participants With a Minimal Residual Disease (MRD) Response
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.
Measured: 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.
Duration of Minimal Residual Disease (MRD) Response - on Treatment
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.
Measured: From start of treatment till end of trial (EOT) visit, up to 61 weeks.
Duration of Minimal Residual Disease (MRD) Response - Including Extended Follow up Visits
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.
Measured: 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.
Progression-free Survival (PFS) - on Treatment
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 -Bone marrow plasma cell percentage; absolute percentage had to be >10% -Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas -Development of hypercalcaemia (corrected serum calcium >11.5 mg/dL or 2.65 Millimole/Liter) that was attributed solely to the plasma cell proliferative disorder.
Measured: From start of treatment till end of trial (EOT) visit, up to 61 weeks.
Progression-free Survival (PFS) - Including Extended Follow up Visits
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 -Bone marrow plasma cell percentage; absolute percentage had to be >10% -Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas -Development of hypercalcaemia (corrected serum calcium >11.5 mg/dL or 2.65 Millimole/Liter) that was attributed solely to the plasma cell proliferative disorder
Measured: 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.
Serum Concentration at Steady State of BI 836909 (Css)
Serum concentration at steady state of BI 836909 (Css).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study start8 Jul 2015
- Primary completion17 Jul 2018
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514239
- Sponsor's protocol ID
- 1351.1
- Other IDs
- 2014-004896-22, 2014
- Status last verified
- Feb 2022
- First submitted
- 21 May 2015
- Last updated
- 24 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Publications
Topp MS, Duell J, Zugmaier G, Attal M, Moreau P, Langer C, Kronke J, Facon T, Salnikov AV, Lesley R, Beutner K, Kalabus J, Rasmussen E, Riemann K, Minella AC, Munzert G, Einsele H. Anti-B-Cell Maturation Antigen BiTE Molecule AMG 420 Induces Responses in Multiple Myeloma. J Clin Oncol. 2020 Mar 10;38(8):775-783. doi: 10.1200/JCO.19.02657. Epub 2020 Jan 2.
PubMed 31895611
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase I, Dose Escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Doses of BI 836909 in Relapsed and/or Refractory Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT02514239
- Acronym / sponsor ID
- 1351.1
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2015 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Posted 22 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Intravenous Infusion of BI 836909 (0.2 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (0.4 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (0.8 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (1.6 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (13 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (25 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (50 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (100 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (200 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (400 μg/d) | Experimental | Drug: BI 836909 |
| Intravenous Infusion of BI 836909 (800 μg/d) | Experimental | Drug: BI 836909 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with a documented diagnosis of relapsed and/or refractory multiple myeloma who progressed after at least two prior treatment regimens, including both proteasome inhibitor as well as an immune-modulatory drug at time of screening
- must have measurable disease, defined by one or more of following at time of screening:
- Relapse or progression of disease with an indication for therapy as per investigator´s judgement at time of screening
- ECOG Performance Status 0, 1 or 2 at time of screening
- Age >= 18 years at time of screening
Key exclusion criteria (25 listed)
- Plasma cell leukemia
- Extramedullary relapse of multiple myeloma
- Known central nervous system involvement by multiple myeloma
- Last anticancer treatment < 2 weeks prior to visit 1
- Last treatment with a therapeutic antibody less than 6 weeks prior to visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 836909Also: AMG 420Intravenous Infusion of BI 836909. | Drug | Intravenous Infusion of BI 836909 (0.2 μg/d), Intravenous Infusion of BI 836909 (0.4 μg/d), Intravenous Infusion of BI 836909 (0.8 μg/d), Intravenous Infusion of BI 836909 (1.6 μg/d), Intravenous Infusion of BI 836909 (100 μg/d), Intravenous Infusion of BI 836909 (13 μg/d), Intravenous Infusion of BI 836909 (200 μg/d), Intravenous Infusion of BI 836909 (25 μg/d), Intravenous Infusion of BI 836909 (3.2 μg/d), Intravenous Infusion of BI 836909 (400 μg/d), Intravenous Infusion of BI 836909 (50 μg/d), Intravenous Infusion of BI 836909 (6.5 μg/d), Intravenous Infusion of BI 836909 (800 μg/d) |
Primary outcome
The Maximum Tolerated Dose (MTD) of BI 836909
Time frame: 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.
The Number of Patients With Dose-limiting Toxicities (DLTs)
Time frame: 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.
9 secondary outcomes
Number of Participants With an Objective Response
Time frame: 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.
Duration of Objective Response - on Treatment
Time frame: From start of treatment till end of trial (EOT) visit, up to 61 weeks.
Duration of Objective Response - Including Extended Follow up Visits
Time frame: 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.
Number of Participants With a Minimal Residual Disease (MRD) Response
Time frame: 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.
Duration of Minimal Residual Disease (MRD) Response - on Treatment
Time frame: From start of treatment till end of trial (EOT) visit, up to 61 weeks.
Duration of Minimal Residual Disease (MRD) Response - Including Extended Follow up Visits
Time frame: 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.
Progression-free Survival (PFS) - on Treatment
Time frame: From start of treatment till end of trial (EOT) visit, up to 61 weeks.
Progression-free Survival (PFS) - Including Extended Follow up Visits
Time frame: 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.
Serum Concentration at Steady State of BI 836909 (Css)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31895611Topp MS, Duell J, Zugmaier G, Attal M, Moreau P, Langer C, Kronke J, Facon T, Salnikov AV, Lesley R, Beutner K, Kalabus J, Rasmussen E, Riemann K, Minella AC, Munzert G, Einsele H. Anti-B-Cell Maturation Antigen BiTE Molecule AMG 420 Induces Responses in Multiple Myeloma. J Clin Oncol. 2020 Mar 10;38(8):775-783. doi: 10.1200/JCO.19.02657. Epub 2020 Jan 2.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 836909 in people with Multiple Myeloma, run by Boehringer Ingelheim at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Maximum Tolerated Dose (MTD) of BI 836909 (time frame: Cycle 1, up to 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02514239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.