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Learn more about a clinical study for
relapsed and/or refractory multiple myeloma (RRMM)

Myeloma represents less than 1% of all cancer cases globally and within the community multiple myeloma represents the second most common blood cancer.

Myeloma is a cancer of a specific type of immune cell known as a plasma cell. When you have been diagnosed with myeloma, this means that many plasma cells are accumulated in a malignant fashion within the bone marrow, leading to bone destruction.

Myeloma as a disease, remains incurable despite several treatment choices and unfortunately, even after excellent initial therapy and maintenance, patients with myeloma tend to relapse.

This study is looking for adult individuals (at least 18 years-old) who have RRMM (this means that your myeloma has returned). 

Sanofi believes that everyone should have the opportunity to participate in clinical trials, especially those who have been historically under-represented. 

Complete a brief questionnaire to help determine if you may qualify to be referred to a site recruiting in your area for further evaluation for potential participation in this clinical study.

Am I eligible?

What is the purpose of the study?

This study will compare the overall response rate obtained with the sub-cutaneous (SC) injection of isatuximab (using an investigational wearable injector device) versus intravenous (IV) infusion of isatuximab, both in combination with pomalidomide and dexamethasone (isatuximab, pomalidomide and dexamethasone combination is an approved standard of care in relapse/refractory multiple myeloma).

What are the investigational medication and injector device?

  • The IV infusion of isatuximab is approved by FDA, EMA (and other Health Authority Agencies) for the treatment of adults with RRMM.    
  • The sub-cutaneous injection of isatuximab is an experimental way of delivering the study drug, which means health authorities have not approved this administration route for the treatment of RRMM.
  • Similarly, the wearable injection device used for this sub-cutaneous administration is an experimental device, which means health authorities have not approved the device yet.
  • Assignment to either the Isatuximab intravenously (IV) or Isatuximab sub-cutaneously (SC) group will be done by a random electronic process.  You have a 1 in 2 (50%) chance of receiving Isatuximab IV or Isatuximab SC, like a "flip of a coin". 

Study Information

How many study visits will there be?

The study has 4 periods. You will need to come to the study site at each period:
  • Screening: visit to determine if this study is right for you.
  • Treatment: isatuximab will be given in "cycles". You will continue to receive the study treatment unless your disease gets worse, or if you experience unacceptable side effects, or until either you or your study doctor decide to stop the study drug.
  • End of Study: visit performed approximately 30 days (about 1 month) after stopping the investigational medication.
  • Follow-Up: visit performed every 12 weeks (3 months) after stopping the investigational medication. 

What are the isatuximab administration regimens?

During Cycle No 1: Isatuximab will be given once weekly for the first 4 weeks.

During Cycle No 2 (and onwards): Isatuximab will be given every 2 weeks (on days 1 and 15 of a 4-week cycle).

Each treatment cycle will last 28 days (about 4 weeks).

What are the pomalidomide and dexamethasone administration regimens?

Pomalidomide will be given orally on days 1 to 21 of each cycle.

Dexamethasone will be given orally once weekly (on days 1, 8, 15 and 22 of each cycle).

How many people are in the study?

This study will enroll approximately 534 patients in study sites across North & South Americas, Europe, Asia & Oceania.

What is expected if I qualify and decide to participate?

  • To attend the scheduled visits and allow the tests or procedures to be performed as planned. 
  • To complete the study participant diary and questionnaires regularly as instructed by the study doctor.   
  • To inform the study doctor or study staff before stopping or modifying your medication(s) or before starting any new medication(s).
Am I eligible?


What is a clinical research study?

Clinical research studies are used to show if/how an investigational medication works and to find out if it is safe. They can also be referred to as clinical trials.

Clinical studies are run by qualified healthcare professionals. The doctors and other healthcare providers are responsible for the study-related care of the people that participate (or enroll) in these studies. Clinical trials are a mandatory part of the process that leads to an approval, which is required before a drug can be marketed.

Independent committees (called Institutional Review Boards or IRBs) are made up of medical and non-medical people, who also watch over clinical research studies, to make sure that the people who enroll are properly and adequately informed and consent prior to study participation.

Why are clinical trials conducted?

Clinical trials are essential to the development of new interventions (drugs, vaccines, procedures, devices) that help people to live longer and with less pain or disability.

They help researchers to understand what does and doesn’t work in humans that cannot be learned in the laboratory or in animals. Clinical trials also help doctors decide if the side effects of an investigational treatment are acceptable when weighed against the potential benefits.

How do clinical trials work?

Clinical trials must adhere to Good Clinical Practices (GCP), rigid standards that clearly state what is allowed by medical professionals during a clinical trial.

Clinical trials follow rigid and specific testing procedures designed to help researchers determine the safety and effectiveness of the investigational drug or medical treatment being studied.

Why should I join a clinical research study?

Thousands of people volunteer to participate in clinical trials every year. The reasons for participation vary, but all of them help to advance medicine. Some reasons include:

  • Medical supervision. Some people have a disease for which there is no approved treatment. They might join a clinical trial in the hopes of receiving an investigational medicine.
  • Contribute to future treatments. Many participants wish to help future patients. This has been reported by both patients and healthy volunteers.
  • Help improve the lives of others. Some people participate with the hope of helping others. The investigational drug or vaccine could benefit other patients and, in some cases, save lives.

Who can participate in a study?

Every clinical trial has a set of criteria that study participants must meet in order to participate, including agreeing to sign an informed consent form and HIPAA (Health Insurance Portability and Accountability Act) authorization.

What is an informed consent?

Before deciding to participate in a clinical study, potential participants will go through a process called "informed consent". This is designed to help the participant learn more about the clinical trial before deciding whether or not to participate. 

Potential participants are given detailed information about the study. This includes the purpose, possible risks, potential benefits, how long it will take, what procedures are required and whom to contact with any questions or issues. 

Once potential participants have no further questions, the document is signed indicating the decision to participate.  An informed consent is designed to protect the study participant. It is not a contract.  A participant can ask questions or stop participating without any reason and at any time, even before the study is over.

What is an open label study?

Both the study participant and study doctor will know the treatment assignment.

What is a Phase III (Phase 3) trial?

Researchers compare the investigational medication with the current standard treatment or placebo. They monitor any side effects very closely. Larger groups of patients (typically several hundred to thousands of people) participate in different Phase 3 clinical trials. These studies can take many years to complete and are often completed in many different locations.

The purpose of a Phase 3 trial is to determine whether the investigational medication is safe and if it has a therapeutic (beneficial) effect.

In most cases, a study participant and study doctor will not know whether they have received the investigational medication, an existing treatment, or placebo. This helps minimize any bias.

What type of study-related medical care is provided during the study?

All study-related medical care related to the study is provided, including study-related exams, study-related medications and other study-related medical care. There is no insurance required to participate. All study-related medical care will be explained.

Studies may also offer compensation in return for travel.

Is it safe to participate in a clinical trial?

All clinical trials have possible risks, some of which are known before the study starts. Before deciding to participate, the study risks will be explained. Study participants are closely monitored during the study.

While side effects may occur with any investigational medication being studied, the safety and well-being of study participants are top priorities for the sponsors, doctors, nurses and research professionals who conduct clinical trials.

Study participants can decide at any point to end participation.

What about clinical trials participation during COVID-19?

This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19. Each individual site location will review their protocols including mask wearing, social distance, pre-appointment check in. Study sites are medical facilities where COVID safety procedures are followed.

The COVID-19 vaccine can be administered before entering in the study or afterwards, without needing study drug interruption. This should be discussed with your study doctor.

Can I speak with someone if I have questions?

Yes, after you complete the online questionnaire and give permission to be contacted, a study representative will contact with you. You can ask questions at any time, before deciding to participate and during study conduct.

References: 1-International Agency for Research on Cancer. Fact sheets by population. GLOBOCAN 2012; 2-Multiple myeloma: an overview/Prof. Parameswaran Hari/Medical College of Wisconsin, US.

v1.0, 29Aug2022