Study of Teclistamab for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying Relapsed/Refractory Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The treatment being tested is called teclistamab, which is a special type of medication known as a bispecific antibody. This means it is designed to target two different proteins at the same time, helping the immune system to better recognize and attack the cancer cells. Teclistamab is given as a solution for injection under the skin.

The purpose of this study is to explore the safety and effectiveness of teclistamab in patients whose multiple myeloma has returned or has not responded to previous treatments. The study is divided into three parts. In the first part, different doses of teclistamab are tested to find the safest dose to use. In the second part, the focus is on understanding how well patients tolerate this dose. Finally, in the third part, the study looks at how effective teclistamab is in treating the disease.

Participants in the study will receive regular injections of teclistamab and will be monitored closely by the research team. The study aims to gather important information about how teclistamab works in treating relapsed or refractory multiple myeloma, which could lead to new treatment options for patients in the future.

1 joining the study

Upon joining the study, confirmation of a diagnosis of multiple myeloma is required. This is a type of cancer that affects plasma cells in the bone marrow.

A performance status score is assessed to ensure the ability to perform daily activities. A score of 0 or 1 is necessary, indicating full activity or some symptoms but no bed rest required.

A negative pregnancy test is required for female participants of childbearing potential.

2 initial assessment

An initial assessment is conducted to measure the disease. This involves laboratory tests to confirm the presence and extent of multiple myeloma.

3 treatment phase 1: dose escalation

The first phase involves dose escalation to identify a safe dosage of teclistamab. This medication is administered as a solution for injection under the skin (subcutaneous use).

The frequency and type of dose-limiting toxicities (DLTs) are monitored to determine the appropriate dosage.

4 treatment phase 2: dose expansion

In the second phase, the safety and tolerability of teclistamab at the identified dosage are further evaluated.

Participants are monitored for any adverse events or serious adverse events, as well as changes in laboratory values.

5 treatment phase 3: efficacy evaluation

The third phase focuses on evaluating the effectiveness of teclistamab at the recommended dosage.

The overall response rate (ORR) is assessed, which includes partial response (PR) or better, according to specific criteria.

6 completion of the study

The study is estimated to conclude by May 31, 2025. Participants will have completed all necessary assessments and treatments by this date.

Who Can Join the Study?

Must have a documented diagnosis of multiple myeloma, which is a type of blood cancer, according to specific medical guidelines.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1, which means the person is fully active or has some symptoms but can carry out light work.
Must have a measurable disease, meaning the multiple myeloma can be measured by tests done in a central laboratory.
If female and able to have children, must have a negative pregnancy test at the start of the study.
Must be willing and able to follow the rules and restrictions of the study.
For Cohort A: Must have received at least 3 previous treatments for multiple myeloma, including specific types of drugs: an IMiD (a type of drug that affects the immune system), a PI (a drug that blocks certain proteins in cancer cells), and an anti-CD38 monoclonal antibody (a drug that targets a specific protein on cancer cells).
For Cohort C: Must have received 3 or more previous treatments that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment, which could be a type of cell therapy or a drug that targets BCMA on cancer cells.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not experienced a return or worsening of their multiple myeloma after treatment.
Patients who are not within the specified age range for the study.
Patients who are pregnant or breastfeeding.
Patients who have certain other medical conditions that might interfere with the study.
Patients who are taking medications that could affect the study results.
Patients who have participated in another clinical trial recently.
Patients who have had a recent infection or illness that could affect their participation.
Patients who have a history of allergic reactions to similar treatments.
Patients who are unable to follow the study procedures or attend the required visits.

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
Centre Hospitalier Universitaire De Lille	Lille	France
Universitaet Leipzig	Leipzig	Germany
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Hospital Clinic De Barcelona	Barcelona	Spain
Karolinska University Hospital	Solna	Sweden
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Aaohvkgdk Ubm	Amsterdam	The Netherlands
Clzxex Hztdukeniax Rxoynjbz Uojfkkciwqzjd Dg Tkehm	Tours	France
Aofpzvy Ogchgjqrsna Pnnk Gkhhvypu Xzgua	Bergamo	Italy
Hcnmwfce Upfruwqtmzhui Hxhgptwy Tyisx y Pilrif Ifhzgabx Conmbj dgewavobolkfgtphl (apke	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	31.03.2017
France	Not recruiting	31.03.2017
Germany	Not recruiting	31.03.2017
Italy	Not recruiting	31.03.2017
Spain	Not recruiting	31.03.2017
Sweden	Not recruiting	31.03.2017
The Netherlands	Not recruiting	31.03.2017

Trial locations

Investigated drugs:

Teclistamab is a humanized bispecific antibody designed to target BCMA (B-cell maturation antigen) and CD3. It is being studied for its potential to treat patients with multiple myeloma, a type of blood cancer. The medication works by directing the body’s immune system to attack and destroy cancer cells. In this clinical trial, researchers are investigating the safety, tolerability, and effectiveness of teclistamab in patients whose multiple myeloma has returned or has not responded to previous treatments.

Relapsed/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 multiple myeloma, the disease returns after a period of improvement. Refractory multiple myeloma refers to the condition not responding to treatment or stopping responding after a while. The disease can cause bone pain, frequent infections, anemia, and kidney problems. As it progresses, it may lead to weakened bones and increased calcium levels in the blood. The condition is characterized by cycles of remission and relapse, making it challenging to manage over time.

Trial ID:

2023-503438-40-00

Protocol code:

64007957MMY1001

Trial Phase:

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

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Study of Teclistamab for Patients with Relapsed or Refractory Multiple Myeloma

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