Study of GEN3014 and Daratumumab for Patients with Relapsed or Refractory Multiple Myeloma and Other Blood Cancers

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What is this study about?

This clinical trial is focused on studying treatments for Relapsed or Refractory Multiple Myeloma and other blood-related cancers, known as hematologic malignancies. The study involves two treatments: GEN3014, also known as HexaBody®-CD38, and DARZALEX, which contains the active substance daratumumab. GEN3014 is a human monoclonal antibody, a type of protein designed to target specific cells, and is given as an infusion into a vein. DARZALEX is a solution for injection that is administered under the skin.

The purpose of this study is to evaluate the safety and tolerability of GEN3014 and to determine the appropriate dose for future studies. Participants will receive either GEN3014 or DARZALEX, and some may receive a placebo. The study will monitor participants for any side effects and how well the treatment is tolerated. The trial will also assess how the body processes GEN3014 and its effects on the disease.

Participants will be involved in the study for a period of time, during which they will receive regular check-ups and monitoring. The study aims to gather information that could help improve treatment options for people with these types of cancers. The trial is expected to continue until 2026, with the goal of finding effective and safe treatment options for patients with relapsed or refractory multiple myeloma and other hematologic malignancies.

1 joining the study

Upon joining the study, the patient will be required to sign an informed consent form. This is a document that confirms the patient’s understanding and agreement to participate in the trial.

The patient must provide fresh bone marrow samples for analysis. This is necessary to confirm eligibility and to gather baseline data.

2 initial assessment

The patient will undergo a series of tests to ensure they meet the eligibility criteria. These tests include laboratory tests, an assessment of performance status, and a review of medical history.

Women of reproductive potential must have a negative pregnancy test and agree to use effective contraception during the trial and for 12 months after the last dose of the study medication.

3 treatment phase

The patient will receive the study medication, GEN3014 (HexaBody®-CD38), which is administered either subcutaneously or intravenously. The specific dosage and frequency will be determined based on the trial’s phase and the patient’s response.

The treatment aims to determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD) of GEN3014. The patient’s safety and the medication’s tolerability will be closely monitored.

4 monitoring and follow-up

Throughout the trial, the patient will be monitored for any side effects or adverse reactions. This includes regular check-ups, laboratory tests, and possibly electrocardiograms (ECGs).

The patient’s response to the treatment will be evaluated through various measures, such as objective response rate and progression-free survival.

5 end of trial

The trial is expected to conclude by March 2026. At the end of the trial, the patient will undergo a final assessment to evaluate the overall impact of the treatment.

The patient will be informed about the results of the trial and any potential next steps regarding their treatment.

Who Can Join the Study?

Must be at least 18 years old.
Must sign an informed consent form before any screening procedures.
Must have fresh bone marrow samples collected during screening.
Must have an acceptable performance status, which is a measure of how well you can carry out daily activities.
Must have acceptable laboratory test results during the screening period.
For women who can have children, must agree to use effective birth control during the trial and for 12 months after the last dose of the study drug. This means using methods that are very reliable in preventing pregnancy.
For women who can have children, must have a negative pregnancy test at screening.
For women, must agree not to donate eggs for assisted reproduction during the trial and for 12 months after the last dose of the study drug.
For men who are sexually active with women who can have children and have not had a vasectomy, must agree to use a barrier method of birth control, like a condom, and must not donate sperm during the trial and for 12 months after the last dose of the study drug.
For patients with relapsed or refractory multiple myeloma (RRMM), must have documented multiple myeloma and show disease progression on the most recent treatment.
For patients with RRMM who have not received anti-CD38 antibody treatment, must have had at least 3 prior treatments, including specific types of drugs, or be resistant to these drugs.
For patients with RRMM who have received anti-CD38 antibody treatment, must have had at least 2 prior treatments and stopped certain medications for at least 4 weeks before the first dose of the study drug.
Must have specific levels of potassium and calcium in the blood.
For patients with relapsed or refractory acute myeloid leukemia (AML), must have failed all conventional therapy and not have a specific type of leukemia called acute promyelocytic leukemia (APL).
For patients with relapsed AML, must have had at least 2 prior therapies, except for a drug called hydroxyurea.
For patients with refractory AML, must have had at least 1 prior therapy, except for hydroxyurea.
Must have a life expectancy of at least 3 months at screening.

Who Cannot Join the Study?

Patients who have not been diagnosed with Relapsed or Refractory Multiple Myeloma or other blood-related cancers cannot participate. Relapsed means the cancer has returned after treatment, and Refractory means the cancer does not respond to treatment.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Pratia Hematologia Sp. z o.o.	Katowice	Poland
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Karolinska University Hospital	Solna	Sweden
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Aalborg University Hospital	Aalborg	Denmark
Pratia S.A.	Skorzewo	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
University Hospital Ostrava	Ostrava	Czechia
Uqxyunllwbyynk Czkgmru Kipcvjeps	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	09.05.2021
Denmark	Not recruiting	09.05.2021
Greece	Not recruiting	09.05.2021
Hungary	Not recruiting	09.05.2021
Poland	Not recruiting	09.05.2021
Spain	Not recruiting	09.05.2021
Sweden	Not recruiting	09.05.2021

Trial locations

Investigated drugs:

Daratumumab

GEN3014 (HexaBody®-CD38) is a medication being studied for its potential to treat relapsed or refractory multiple myeloma and other blood-related cancers. This trial aims to find the right dose of GEN3014 that can be safely given to patients while also evaluating how well patients tolerate the medication. The study is designed to understand the effects of GEN3014 on these types of cancers and to determine the most effective and safe dosage for future treatments.

Relapsed or Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a type 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 damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease can lead to anemia and high levels of calcium in the blood. Over time, it can become more challenging to manage as it becomes resistant to treatments.

Other Hematologic Malignancies – These are cancers that begin in the blood-forming tissue, such as the bone marrow, or in the cells of the immune system. They include various types of leukemia, lymphoma, and myelodysplastic syndromes. These malignancies often progress by disrupting the normal production and function of blood cells, leading to symptoms like fatigue, easy bruising, and increased risk of infections. As the disease advances, it can cause enlargement of the liver, spleen, or lymph nodes. The progression can vary significantly depending on the specific type of hematologic malignancy. They often require ongoing monitoring and management to address the changes in blood cell counts and related symptoms.

Trial ID:

2023-507086-26-00

Protocol code:

GCT3014-01

NCT ID:

NCT04824794

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of GEN3014 and Daratumumab for Patients with Relapsed or Refractory Multiple Myeloma and Other Blood Cancers

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