Study on Talquetamab and Tocilizumab for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects the blood. The study is testing a new treatment called Talquetamab, also known by its code name JNJ-64407564. Talquetamab is a special type of medicine known as a bispecific antibody, which is designed to help the body’s immune system target and fight cancer cells more effectively. The trial also involves another medication called Tocilizumab, which is used to help manage certain side effects that might occur during the treatment.

The purpose of this study is to understand how safe Talquetamab is for patients and to determine the best dose to use in future studies. The trial will also look at how well Talquetamab works in treating Multiple Myeloma. Participants in the study will receive Talquetamab through injections under the skin or through an infusion into a vein. Some participants will also receive Tocilizumab to help prevent or reduce side effects. The study will be conducted in different phases, starting with a small group of participants to find the right dose, and then expanding to include more participants to further evaluate the treatment’s effectiveness and safety.

Throughout the study, participants will be closely monitored by healthcare professionals to track any side effects and to see how well the treatment is working against Multiple Myeloma. The study aims to provide valuable information that could lead to new treatment options for people with this type of cancer. Participants will be required to visit the study site regularly for treatment and check-ups, and the study is expected to continue for several years to gather comprehensive data.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include being 18 years or older, having a documented diagnosis of multiple myeloma, and having previously received at least three lines of therapy.

2 treatment phase 1

The first phase of treatment involves the administration of talquetamab through subcutaneous injection. The dosage and frequency are determined based on individual health assessments.

During this phase, the safety of talquetamab is closely monitored to determine the appropriate dose for the next phase.

3 treatment phase 2

In the second phase, the recommended dose of talquetamab is administered. This phase aims to further evaluate the safety and effectiveness of the treatment.

Regular monitoring continues to assess any side effects or adverse reactions.

4 tocilizumab administration

To manage potential side effects, tocilizumab is administered intravenously. This medication helps prevent or reduce inflammation-related reactions.

The frequency and dosage of tocilizumab are adjusted based on individual response and tolerance.

5 ongoing monitoring

Throughout the trial, regular health assessments are conducted to monitor the patient’s response to the treatment.

These assessments include blood tests, imaging studies, and other evaluations as necessary to ensure safety and effectiveness.

6 completion and follow-up

Upon completion of the treatment phases, a final assessment is conducted to evaluate the overall response to the therapy.

Follow-up visits may be scheduled to monitor long-term effects and gather additional data on the treatment’s impact.

Who Can Join the Study?

Must be 18 years of age or older.
Must have a documented initial diagnosis of multiple myeloma, which is a type of blood cancer.
For Part 1: Must have multiple myeloma that can be measured and has worsened after trying all available treatments, or could not tolerate them.
For Part 2: Must have multiple myeloma that can be measured by a central lab and has worsened after trying all available treatments, or could not tolerate them. This includes specific levels of certain proteins in the blood or urine.
For Part 3: Must have measurable disease for Cohorts A, B, and C, with specific protein levels in the blood or urine.
For Cohort A and C: Must have tried at least three different treatments, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody, but not treatments like CAR-T or bispecific antibodies.
For Cohort B: Must have tried at least three different treatments, including a PI, an IMiD, and an anti-CD38 monoclonal antibody, and have been treated with CAR-T or bispecific antibodies.
Must have completed at least one full cycle of treatment for each therapy tried, unless the disease worsened during that treatment.
Must have evidence of the disease getting worse based on specific criteria within 12 months of the last treatment, except for those who had CAR-T as their last treatment.
Must have an ECOG performance status score of 0 or 1 for Parts 1 and 2, and 0-2 for Part 3. This score measures how well a person can perform daily activities.
Must have certain clinical lab values that meet specific criteria during the screening phase before starting the trial.

Who Cannot Join the Study?

Patients who have a different condition than multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects certain cells in the bone marrow.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study schedule or take the study medication as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had a recent infection or illness that could affect the study cannot participate.
Patients who are taking certain medications that might interfere with the study cannot participate.
Patients who have a history of allergic reactions to similar medications cannot participate.
Patients who have participated in another clinical trial recently cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Salamanca	Salamanca	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Hopital Beaujon	Clichy	France
Cgxgmierq Ugntnyqclaxeis Satfijuxa	Woluwe-Saint-Lambert	Belgium
Hbninwex Uuuwtnammmqpb Mtgrfqc Dl Vdacmjmrgq	Santander	Spain
Iefnczxx Cwzfrd Datxkdwljfjllnufk	L'hospitalet De Llobregat	Spain
Aqmhzmufk Uzz	Amsterdam	The Netherlands
Nhvdllmz Islzqazm Oowpfsvnq Ixr Mbyno Sdqvadumfowlmsvcdqfovdyrixjv Izrdgtpv Boyrrwob	Cracow	Poland
Urfidtglvscsrfednbxjl Wanbfubiw Amp	Wuerzburg	Germany
Ubottxwogwxgco Cbxpvgl Kuroaacef	Gdansk	Poland
Uqwobvcbvn Ok Aiacqna	Edegem	Belgium
Hqmlhxoj Vfed dtomvjbs	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	16.12.2017
France	Not recruiting	16.12.2017
Germany	Not recruiting	16.12.2017
Poland	Not recruiting	16.12.2017
Spain	Not recruiting	16.12.2017
The Netherlands	Not recruiting	16.12.2017

Trial locations

Investigated drugs:

Talquetamab is a humanized bispecific antibody designed to target and bind to two specific proteins, GPRC5D and CD3. It is being studied for its potential to treat patients with relapsed or refractory multiple myeloma, a type of blood cancer. The goal of using talquetamab in this trial is to assess its safety and determine the most effective dose and schedule for future studies. Researchers are also looking at how well it works in treating the cancer.

Tocilizumab is a medication used in this trial to help prevent or reduce the severity of cytokine release syndrome (CRS), a possible side effect of treatments like talquetamab. CRS can occur when the immune system becomes overly active, and tocilizumab helps manage this by blocking a specific protein involved in the inflammatory response.

Investigated diseases:

Plasma cell myeloma

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells, causing fatigue and weakness. Over time, the disease can cause significant complications, including kidney dysfunction and bone lesions.

Trial ID:

2023-504581-29-00

Protocol code:

64407564MMY1001

Trial Phase:

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

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Study on Talquetamab and Tocilizumab for Patients with Relapsed or Refractory Multiple Myeloma

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