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Long-term Safety Study of Daratumumab with Drug Combination for Patients with Multiple Myeloma or Smoldering Multiple Myeloma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety of a medication called Daratumumab when used in combination with standard treatments for a type of bone marrow cancer known as Multiple Myeloma. The study aims to provide ongoing access to this treatment for participants who are benefiting from it in other related studies. Daratumumab is a type of medication known as a monoclonal antibody, which is a protein designed to target and help destroy cancer cells.

Participants in this study will continue to receive Daratumumab either alone or with other treatments they are already receiving. The study will monitor participants over a period to collect data on the long-term safety of the treatment. The treatment is administered through an infusion, which means it is given directly into the bloodstream through a vein. The study will continue until participants no longer need access to Daratumumab through this trial.

The purpose of this study is to ensure that participants who are benefiting from Daratumumab can continue to receive it safely. The study will also gather important safety information to help understand how the treatment works over a longer period. Participants will be monitored regularly to ensure their safety and to assess the ongoing benefits of the treatment. This study is part of a larger effort to improve treatment options for people with Multiple Myeloma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an informed consent form. This form confirms that you understand the purpose and procedures of the study and agree to participate.

    You must meet specific criteria, such as actively receiving daratumumab or other study treatments for multiple myeloma, and continue to benefit from the treatment without experiencing disease progression or unmanageable side effects.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet all the necessary criteria. This includes a negative pregnancy test for female participants of childbearing potential and agreement to use effective contraception methods during the study.

    Male participants must agree to use condoms during activities that allow for the passage of ejaculate and not to donate sperm during the study and for a specified period after the last dose.

  3. Step 3

    Treatment administration

    You will receive daratumumab as part of your treatment regimen. This medication is administered through intravenous use or infusion.

    Other medications may include dexamethasone, pomalidomide, lenalidomide, and carfilzomib, which are taken orally or through infusion, depending on the specific treatment plan.

  4. Step 4

    Ongoing monitoring

    Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to ensure the treatment's effectiveness and manage any side effects.

    You will continue to receive the study treatment as long as you benefit from it and do not experience any significant adverse effects.

  5. Step 5

    Study completion

    The study will continue until no more patients require access to daratumumab through this study, or until alternative access to the medication is available.

    The estimated end date for the study is March 31, 2026, but your participation may end earlier if you no longer benefit from the treatment or if you choose to withdraw.

Who can join the trial?

13 criteria

  • Participants must be actively receiving daratumumab (a type of medication) either alone or with other treatments in certain studies for multiple myeloma or smoldering multiple myeloma.
  • Participants must continue to benefit from the study treatment.
  • Participants must not have experienced worsening of their disease or unmanageable side effects while receiving daratumumab.
  • Participants must not have met the withdrawal criteria set in the original study.
  • Participants must have received their last dose of study treatment within the previous 3 months.
  • The study doctor must believe that the benefits of continuing the study treatment will be greater than the risks.
  • A female participant who can become pregnant must have a negative pregnancy test at the start and agree to further pregnancy tests during the study.
  • A female participant must either be unable to become pregnant or agree to use at least one highly effective method of birth control during the study and for 3 months after the last dose of daratumumab.
  • A female participant must agree not to donate eggs or freeze them for future use during the study and for a specified period after the last dose of study treatment.
  • A male participant must wear a condom during any activity that could result in pregnancy during the study and for a specified period after the last dose of study treatment. If the partner is a female who can become pregnant, she must also use a highly effective method of birth control.
  • A male participant must agree not to donate sperm during the study and for at least 3 months after the last dose of study treatment.
  • Participants must sign an informed consent form, indicating they understand the study's purpose and procedures and are willing to participate.
  • Participants must be willing and able to follow the lifestyle restrictions specified in the study protocol.

Who cannot join the trial?

4 criteria

  • Participants who have not been diagnosed with Multiple Myeloma or Smoldering Multiple Myeloma cannot participate. Multiple Myeloma is a type of cancer that affects certain white blood cells in the bone marrow. Smoldering Multiple Myeloma is an early form of this disease.
  • Participants who are not already part of certain Janssen R&D studies using daratumumab as part of the treatment cannot participate. Daratumumab is a medication used to treat Multiple Myeloma.
  • Participants who are not benefiting from their current treatment in these specific studies cannot participate.
  • Participants from studies that have not reached the clinical cutoff for final analysis cannot participate. This means the study must have reached a certain point where enough data has been collected for analysis.
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Investigated drugs

Daratumumab is a medication used in the treatment of multiple myeloma, which is a type of cancer that affects the bone marrow. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. In this clinical trial, daratumumab is being provided to participants who have been benefiting from its use in previous studies. The goal is to continue offering this treatment to those who need it and to collect long-term safety data.

What is already known about the treatment

Daratumumab – Daratumumab is administered as an injection, typically given intravenously, meaning it's delivered directly into a vein. It is currently used in the medical field for treating multiple myeloma, a type of blood cancer, and is well-documented in medical literature. The main therapeutic use of daratumumab is to help manage and treat multiple myeloma by targeting and binding to a specific protein on the surface of cancer cells, which helps the immune system to identify and destroy these cells. It belongs to a class of drugs known as monoclonal antibodies, which are designed to target specific proteins in the body.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause bone pain, fractures, and anemia due to the reduced production of healthy blood cells. Patients may also experience high calcium levels in the blood, kidney problems, and increased susceptibility to infections. The disease often progresses slowly, but it can become more aggressive over time. Smoldering Multiple Myeloma is an early, asymptomatic form of the disease that may progress to active Multiple Myeloma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500138-27-01Protocol code54767414MMY3030Estimated enrolment207 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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