Study on the Safety and Effectiveness of BGB-11417 Alone and with Dexamethasone, Carfilzomib, Daratumumab, or Pomalidomide for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying treatments for relapsed or refractory multiple myeloma, a type of blood cancer that has returned or is not responding to previous treatments. The study will explore the use of a new medication called BGB-11417, both on its own and in combination with other treatments. These combinations include dexamethasone, a medication that reduces inflammation, and other drugs such as carfilzomib, daratumumab, and pomalidomide. The purpose of the study is to determine the safety and effectiveness of these treatments.

The study will be conducted in two parts. In the first part, different doses of BGB-11417 will be tested to find the most suitable dose when used with the other medications. In the second part, the study will expand to include more patients to further evaluate the safety and effectiveness of BGB-11417 alone and in combination with the other drugs. Patients will receive these treatments through various methods, such as oral tablets, injections, or infusions, depending on the specific medication.

Throughout the study, researchers will monitor patients for any side effects and assess how well the treatments are working. The goal is to find the best treatment options for patients with relapsed or refractory multiple myeloma, particularly those with a specific genetic feature known as t(11;14). This study aims to provide new insights into managing this challenging condition and improving patient outcomes.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of multiple myeloma and previous treatment history.

A fresh bone marrow sample is collected for testing specific genetic markers.

2 part 1: dose escalation

The initial phase involves determining the safe dosage levels of the new medication, BGB-11417, in combination with other drugs.

Medications include dexamethasone (oral and IV), carfilzomib (intravenous infusion), daratumumab (subcutaneous use), and pomalidomide (oral).

The focus is on assessing safety and identifying any side effects.

3 part 2: cohort expansion

This phase evaluates the effectiveness of BGB-11417 alone and in combination with other medications at the recommended doses.

The goal is to measure the response rate and monitor any adverse effects.

The treatment combinations include BGB-11417 with dexamethasone, and with dexamethasone plus carfilzomib.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the treatment’s impact on the condition.

The study aims to track the time to response, duration of response, and overall survival rates.

5 completion of the trial

The trial is expected to conclude by March 2027.

Final assessments will determine the overall effectiveness and safety of the treatment combinations.

Who Can Join the Study?

Must have an ECOG performance status of 0 to 2. This is a scale that measures how well you can perform daily activities.
Must have a confirmed diagnosis of multiple myeloma.
Must have a measurable disease, which means one of the following:
- M-spike in blood is 500 mg/dL or more, or
- Urine protein M-spike is 200 mg/day or more, or
- Serum free light chains are 10 mg/dL or more, with an abnormal kappa to lambda ratio.
Must have relapsed or progressive multiple myeloma after any treatment or be unresponsive to the most recent treatment.
- Relapsed means the disease has returned after treatment.
- Refractory means the disease does not respond to treatment or worsens within 60 days of the last treatment.
For Part 1, must have relapsed or progressive disease and have had 3 or more previous treatments, including a proteasome inhibitor, an IMiD (a type of drug), and an anti-CD38 monoclonal antibody.
For Part 2 (Cohorts 1 and 2), must have relapsed or progressive disease and have had 3 or more previous treatments, including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody.
For Part 2 (Cohorts 3, 4, and 5):
- Must have relapsed or progressive disease and have had 1 or more previous treatments.
- Must have been treated with a combination therapy that includes an anti-CD38 monoclonal antibody.
- Previous treatment with carfilzomib is allowed, but you must not be considered resistant to it and must not have received it in the past 6 months.
Must test positive for t(11;14) using a specific test in a central laboratory. This involves collecting a fresh bone marrow sample during screening.
Must have adequate organ function, which includes:
- Hemoglobin level of 8.0 g/dL or more within 7 days before the first dose, without the need for growth factor support or transfusions.
- Platelet count of 75,000/μL or more within 7 days before the first dose, without the need for growth factor support or transfusions.
- Absolute neutrophil count (ANC) of 1000/mm³ or more within 7 days before the first dose.
- ALT and AST levels that are 3 times or less the upper limit of normal, and total bilirubin that is 2 times or less the upper limit of normal.
- Serum creatinine level that is 1.5 times or less the upper limit of normal, or a creatinine clearance of 45 mL/min/1.73 m² or more.

Who Cannot Join the Study?

Patients who have a different type of cancer other than relapsed or refractory multiple myeloma cannot participate. This means the study is only for those whose multiple myeloma has returned or did not respond to treatment.
Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups only.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have certain other health conditions that might interfere with the study or make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
Patients who are currently participating in another clinical trial cannot join this study, to avoid interference with results.
Patients who have had a recent major surgery or are recovering from a major illness may not be eligible to participate.
Patients who have a history of allergic reactions to the study medications or similar drugs cannot participate.
Patients who have certain infections or diseases that could affect the study results or their safety cannot join the study.
Patients who have a history of substance abuse or other conditions that might affect their ability to follow the study requirements cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Universitaetsklinikum Aachen AöR	Aachen	Germany
Hospital San Pedro De Alcantara	Caceres	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Alexandra Hospital	Athens	Greece
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Universita’ Politecnica Delle Marche	Ancona	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Uzpthvkssj Mdivuat Cechsp Hxdpsjxjnlqjtrwpi	Hamburg	Germany
Isljqcon Rslfbaics Ptw Lc Slhitd Dxs Tsceva Dsyq Ahuiynv Izzo Sorosv	Meldola	Italy
Uzlmsnipudontrzzikgxb Wjewrknaf Abg	Wuerzburg	Germany
Azhmjay Upnsq Snqzonaje Lcjlfh Du Bdkjwet	Bologna	Italy

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.04.2024
Germany	Recruiting	01.04.2024
Greece	Recruiting	01.04.2024
Italy	Recruiting	01.04.2024
Spain	Recruiting	01.04.2024

Trial locations

Investigated drugs:

Sonrotoclax is an investigational medication being studied for its potential to treat patients with relapsed or refractory multiple myeloma, particularly those with a specific genetic marker known as t(11;14). It is being tested both as a standalone treatment and in combination with other medications to determine its safety and effectiveness.

Dexamethasone is a type of corticosteroid medication that is used to reduce inflammation and suppress the immune system. In this trial, it is combined with other treatments to help manage multiple myeloma and enhance the effects of other medications.

Carfilzomib is a medication used to treat multiple myeloma by inhibiting the proteasome, a protein complex that breaks down proteins in cells. By blocking this process, carfilzomib can help kill cancer cells. It is being tested in combination with dexamethasone and sonrotoclax to assess its effectiveness in this trial.

Daratumumab is a monoclonal antibody that targets a specific protein on the surface of multiple myeloma cells, helping the immune system to identify and destroy these cancer cells. In this study, it is used in combination with dexamethasone and sonrotoclax to evaluate its potential benefits for patients.

Pomalidomide is a medication that modifies the immune system and has anti-cancer effects. It is used in combination with dexamethasone and sonrotoclax in this trial to explore its role in treating multiple myeloma, particularly in patients who have not responded to other treatments.

Relapsed or Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In relapsed or refractory cases, the disease has returned after treatment or does not respond to standard therapies. It typically progresses by causing an overproduction of abnormal plasma cells, leading to bone damage, kidney issues, and weakened immune function. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease can be challenging to manage due to its resistance to treatment and tendency to recur.

Trial ID:

2023-507751-30-00

Protocol code:

BGB-11417-105

NCT ID:

NCT04973605

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of BGB-11417 Alone and with Dexamethasone, Carfilzomib, Daratumumab, or Pomalidomide for Patients with Relapsed or Refractory Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?