A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)

August 24, 2026 updated by: GlaxoSmithKline

A Phase 2, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15)

This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.

The main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Nantes, France, 44093
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cyrille Touzeau
      • Paris, France, 75012
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zoe Van De Wyngaert
      • Paris, France, 75651
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laurent Garderet
      • Paris, France, 75475
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexis Talbot
      • Saint-Etienne, France
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emilie Chalayer
    • Nord
      • Dunkirk, Nord, France, 59240
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Helene Demarquette
  • Germany
      • Frankfurt, Germany, 60389
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Moritz Bewarder
      • Hamburg, Germany, 22763
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hans Salwender
      • Karlsruhe, Germany, 76133
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stefanie Lemnitz
      • Koblenz, Germany, 56068
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Guenther
      • München, Germany, 80634
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marcus Hentrich
        • Contact:
        • Contact:
  • Greece
      • Athens, Greece, 11528
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meletios Athanasios Dimopoulos
      • Athens, Greece, 106 76
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • SOSANA DELIMPASI
      • Periohi Dragana Alexand, Greece, 68100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emmanouil Spanoudakis
      • Thessaloniki, Greece, 54007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eirini Katodritou
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 570 10
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michail Iskas
        • Contact:
        • Contact:
  • Japan
      • Aichi, Japan, 467-8602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shinsuke Iida
      • Chiba, Japan, 277-8567
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kaichi Nishiwaki
      • Ehime, Japan, 790-8524
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tomoaki Fujisaki
        • Contact:
        • Contact:
      • Fukushima, Japan, 960-1295
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Takayuki Ikezoe
        • Contact:
        • Contact:
      • Gunma, Japan, 371-8511
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hiroshi Handa
        • Contact:
        • Contact:
      • Hokkaido, Japan, 060-8543
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masayoshi Kobune
      • Ishikawa, Japan, 920-8641
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroyuki Takamatsu
      • Numakunai, Japan, 028-3695
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shigeki Ito
        • Contact:
        • Contact:
      • Okayama, Japan, 701-1192
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazutaka Sunami
      • Osaka, Japan, 590-0197
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shinya Rai
      • Sendai, Japan, 983-8520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • TORU IZUMI
      • Tokyo, Japan, 105-8471
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kazuhito Suzuki
        • Contact:
        • Contact:
      • Yamanashi, Japan, 409-3898
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Keita Kirito
        • Contact:
        • Contact:
  • Netherlands
      • Amersfoort, Netherlands, 3813 TZ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josien Regelink
      • Hoofddorp, Netherlands, 2130 AT
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aart Beeker
      • The Hague, Netherlands, 2545 AA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paula F. Ypma
  • South Korea
      • Seoul, South Korea, 03722
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin Seok Kim
      • Seoul, South Korea, 138-736
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dok Hyun Yoon
        • Contact:
        • Contact:
      • Seoul, South Korea, 110-774
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Youngil Koh
      • Seoul, South Korea, 137701
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • chang-ki min
      • Ulsan, South Korea, 44033
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jae-Cheol Jo
        • Contact:
        • Contact:
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kihyun Kim
        • Contact:
        • Contact:
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Albert Oriol
      • Córdoba, Spain, 14004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel Ángel Álvarez Rivas
      • Gijón, Spain, 33394
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Esther González Garcia
        • Contact:
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Joaquin Martinez Lopez
        • Contact:
        • Contact:
      • Madrid, Spain, 28006
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Arancha Alonso
        • Contact:
        • Contact:
      • Málaga, Spain, 29010
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • RICARDA GARCIA SANCHEZ
        • Contact:
        • Contact:
      • Salamanca, Spain, 37007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Victoria Mateos Manteca
      • Vitoria-Gasteiz, Spain, 01009
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xabier Gutierrez Lopez de Ocariz
        • Contact:
        • Contact:
    • Andalusia
      • Jerez de la Frontera, Andalusia, Spain, 11407
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sebastian Garzon Lopez
        • Contact:
        • Contact:
  • United States
    • California
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nihal Abdulla
      • Torrance, California, United States, 90505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Swati Sikaria
      • Whittier, California, United States, 90602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Brian Cheng
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dennis Slater
        • Contact:
        • Contact:
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shivtaj Mann
    • Georgia
      • Macon, Georgia, United States, 31210
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bradley Sumrall
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Dalovisio
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Victor Priego
        • Contact:
        • Contact:
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Cuevas
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • V. Roger Holden
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ankit Anand
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jesus Berdeja

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Participants are eligible to be included in the study only if all of the following criteria apply:

Applicable to All Arms - BPd, BVd, BKd:

  • Male or female, 18 years or older (at the time consent is obtained).
  • Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2.
  • Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.

  • Must have at least 1 aspect of measurable disease, defined as one the following:

    1. Urine M-protein excretion ≥200 mg/24 h, or
    2. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or
    3. Free Light Chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (<0.26 or >1.65) only if patient has no measurable urine or serum M spike.

  • Patients with a history of Autologous Stem Cell Transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:

    1. ASCT was >100 days prior to the first dose of study medication,
    2. No active bacterial, viral, or fungal infection(s) present.
  • All prior treatment-related toxicities (defined by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0) must be ≤Grade 1 at the time of enrollment, except for alopecia.
  • Adequate organ system functions as defined by the laboratory assessments.
  • Contraceptive requirements for men and women per local regulations; strict pregnancy prevention for women of childbearing potential (WOCBP), including negative pregnancy tests and use of highly effective contraception.
  • Male participants must refrain from sperm donation and must use a condom plus an additional highly effective method of contraception if sexually active with a woman of childbearing potential.

Specific Inclusion Criteria for BPd arm:

• Prior treatment must include a lenalidomide-containing regimen, with lenalidomide administered for at least 2 consecutive cycles.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Applicable for all (BPd, BVd, BKd):

  • Active plasma cell leukemia at Screening.
  • Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS).

  • Previous or concurrent invasive malignancy other than MM, except:

    1. The disease must be considered medically stable for at least 2 years; or
    2. The patient must not be receiving active therapy, other than hormonal therapy for this disease.
  • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
  • Plasmapheresis within 7 days prior to the first dose of study intervention.
  • Patients after prior allogeneic stem cell transplant
  • Any major surgery within 4 weeks prior to start of treatment, except for bone stabilizing surgery.
  • Evidence of active mucosal or internal bleeding.
  • Intolerance or contraindications to anti-viral prophylaxis.
  • Current corneal epithelial disease except for mild punctate keratopathy.
  • Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention.
  • Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety). Patients with isolated proteinuria resulting from MM are eligible, provided they fulfill certain criteria
  • Received prior B-cell maturation antigen (BCMA)-targeted therapy.
  • Contact lenses are prohibited while receiving belantamab mafodotin treatment. Use may be restarted after a qualified eye care specialist confirms there are no other contraindications. Bandage contact lenses are permitted during study treatment as directed by the treating eye care specialist.
  • HIV infection unless well-controlled, no recent AIDS-defining infections, and adequate CD4+ count.
  • Significant liver dysfunction (ALT >2.5x ULN, bilirubin >1.5x ULN, cirrhosis, unstable liver/biliary disease).
  • Positive hepatitis B or C markers unless criteria for resolved infection are met.
  • Evidence of cardiovascular risk including any of the following: untreated arrhythmias, recent MI/ACS/angioplasty/bypass, NYHA III/IV heart failure, uncontrolled hypertension, QTc prolongation.

Specific Exclusion Criteria for BPd Arm:

  • Received prior treatment with or intolerant to pomalidomide.
  • Active or history of venous and arterial thromboembolism within the past 3 months.

Specific Exclusion Criteria for BVd Arm:

  • Intolerant to bortezomib or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m² twice weekly or within 60 days of completing that treatment).
  • Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.

Specific Exclusion Criteria for BKd Arm:

  • Intolerant to carfilzomib or refractory to carfilzomib (defined as progressive disease during treatment with a carfilzomib-containing regimen or within 60 days of completing that treatment).
  • Known history of allergy to captisol (i.e., cyclodextrin derivatives) used to solubilize carfilzomib.
  • Left ventricular ejection fraction <40% as assessed by transthoracic echocardiogram.
  • Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment.
  • Intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
  • Known pulmonary hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Other Names:
  • Blenrep
Drug: Dexamethasone
Dexamethasone will be administered.
Drug: Pomalidomide
Pomalidomide will be administered.
Other Names:
  • Imnovid
Experimental: Belantamab mafodotin + Bortezomib + Dexamethasone (BVd)
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Other Names:
  • Blenrep
Drug: Dexamethasone
Dexamethasone will be administered.
Drug: Bortezomib
Bortezomib will be administered.
Other Names:
  • Velcade
Experimental: Belantamab mafodotin + Carfilzomib + dexamethasone (BKd)
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Other Names:
  • Blenrep
Drug: Dexamethasone
Dexamethasone will be administered.
Drug: Carfilzomib
Carfilzomib will be administered.
Other Names:
  • Kyprolis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to approximately 52 months
ORR is defined as the percentage of participants with a confirmed partial response [PR] or better (i.e., PR, very good partial response (VGPR), complete response [CR], stringent complete response [sCR]). Responses will be assessed using International Myeloma Working Group (IMWG) criteria.
Up to approximately 52 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Response Rate (CRR)
Time Frame: Up to approximately 52 months
CRR is defined as the percentage of participants with a confirmed CR or better (i.e., CR, sCR).
Up to approximately 52 months
Minimal Residual Disease (MRD) Negativity Rate
Time Frame: Up to approximately 52 months
MRD negativity rate is defined as the percentage of participants who achieve MRD negative status (as assessed by Next generation sequencing [NGS] at 10^-5 threshold) at least once during the time of confirmed CR or better response as per IMWG.
Up to approximately 52 months
Duration of Response (DoR)
Time Frame: Up to approximately 52 months
DoR is defined as the time from first documented evidence of PR or better until PD or death due to any cause.
Up to approximately 52 months
Number of participants with adverse events (AEs), Serious adverse events (SAEs) by severity
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Number of participants with AEs leading to dose modifications or AEs leading to treatment discontinuation
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Number of Participants With Ocular Findings on Ophthalmic Examination by severity
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Proportion of participants showing concordance between patient-reported ocular symptoms and ophthalmic examination findings
Time Frame: Up to approximately 52 months
Ophthalmic examination findings will be summarized, and contingency table will be constructed to assess the concordance between the results from patient questionnaires (Ocular Surface Disease Index [OSDI], PRO-CTCAE ocular scale, and PROSIM-Q) and findings from clinician assessments (CTCAE for eye disorders and Keratopathy and Visual Acuity [KVA] grading scale). The proportion of participants showing concordance will be calculated from this analysis.
Up to approximately 52 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 224317
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523117-28-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings