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Comparison of intravenous versus subcutaneous isatuximab with lenalidomide, bortezomib and dexamethasone in newly diagnosed multiple myeloma patients eligible for transplant

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study focuses on treating patients with newly diagnosed Multiple Myeloma, a type of blood cancer that develops in plasma cells found in bone marrow. The research examines two different methods of administering isatuximab - either through intravenous infusion into a vein or by subcutaneous injection under the skin. Both methods will be combined with other medications including lenalidomide, bortezomib, and dexamethasone.

The main purpose of this research is to determine if giving isatuximab as an injection under the skin works as well as giving it through an intravenous infusion when combined with the other medications. The study will compare these two methods in patients who are eligible for stem cell transplantation.

During the treatment, patients will receive one of the two forms of isatuximab along with the standard combination of medications. The treatment period will last up to 18 months. Throughout the study, doctors will monitor how well the treatment is working by measuring the amount of myeloma cells in the body and checking for signs that the disease is responding to the therapy.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation and diagnosis

    Confirmation of multiple myeloma diagnosis requiring treatment

    Medical assessment to confirm eligibility for high-dose therapy and stem cell transplant

    Basic health checks including performance status evaluation

    Required tests to measure disease markers in blood and urine

  2. Step 2

    Treatment assignment

    Random assignment to one of two treatment groups

    Both groups receive the same medications, but with different methods of isatuximab administration:

    Group 1: isatuximab given through intravenous infusion (into a vein)

    Group 2: isatuximab given through subcutaneous injection (under the skin)

  3. Step 3

    Induction therapy

    Treatment with four medications:

    - Isatuximab (either by intravenous infusion or subcutaneous injection)

    - Lenalidomide (oral capsules in various strengths: 5mg, 10mg, 15mg, or 25mg)

    - Bortezomib (Velcade) as subcutaneous injection

    - Dexamethasone (oral or intravenous)

    Regular monitoring of response to treatment

    Assessment of disease status using blood and bone marrow tests

  4. Step 4

    Response evaluation

    Assessment of treatment response after induction therapy

    Evaluation of disease status using standard criteria

    Bone marrow examination to check for remaining disease cells

    Completion of questionnaire about satisfaction with therapy

Who can join the trial?

12 criteria

  • Must have a confirmed diagnosis of untreated Multiple Myeloma that requires treatment
  • Must be between 18 and 70 years old
  • Must provide written informed consent before joining the study
  • Must be eligible for high-dose melphalan therapy (a type of chemotherapy) and stem cell transplantation
  • Must have measurable disease, shown by at least one of these:
    • Blood protein level ≥ 10 g/L
    • Urine protein level ≥ 200 mg in 24 hours
    • Specific blood protein levels meeting certain criteria
    • Must have a WHO performance status of 0-2 (meaning ability to perform daily activities with minimal assistance)
    • Women who can become pregnant must have a negative pregnancy test
    • All men and women who can have children must use effective birth control during the entire treatment
    • Must agree not to donate blood during treatment with lenalidomide and for 28 days after stopping it
    • Must be able to understand the nature of the study and its consequences

Who cannot join the trial?

14 criteria

  • Prior treatment with any anti-myeloma therapy (except for emergency use of short-term steroids)
  • History of other cancer within 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ
  • Plasma cell leukemia (a rare and aggressive type of blood cancer where plasma cells are found in high numbers in the blood)
  • Known hypersensitivity (severe allergic reaction) to any of the study medications
  • Active or chronic hepatitis B or hepatitis C infection
  • Positive HIV test
  • Significant heart conditions including heart failure or recent heart attack (within 6 months)
  • Uncontrolled high blood pressure
  • Major surgery within 4 weeks before starting the study
  • Active, uncontrolled infections requiring treatment
  • Pregnancy or breastfeeding
  • Mental conditions that could interfere with study participation
  • Participation in another clinical trial within 4 weeks before this study
  • Known allergies to medications containing monoclonal antibodies
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Investigated drugs

  • Lenalidomide

    is a medication used to treat multiple myeloma. It works by helping the immune system fight cancer cells and by blocking the growth of new blood vessels that feed tumors.

  • Bortezomib

    is a targeted therapy that belongs to a class of drugs called proteasome inhibitors. It works by blocking certain proteins in cancer cells, causing them to die.

  • Dexamethasone

    is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In cancer treatment, it's often used to reduce side effects and enhance the effectiveness of other medications.

  • Isatuximab

    is an antibody therapy that targets a specific protein called CD38 found on the surface of multiple myeloma cells. It helps the immune system identify and destroy cancer cells. In this trial, it's being tested in two different forms: one given through an intravenous (IV) infusion into the vein, and another given as a subcutaneous (SC) injection under the skin.

What is already known about the treatment

  • Lenalidomide

    An oral immunomodulatory drug administered in tablet form that is widely used in the treatment of multiple myeloma. It works by enhancing the immune system's response against cancer cells while also directly inhibiting the growth of myeloma cells, making it particularly effective when combined with other treatments. This medication belongs to the class of immunomodulatory drugs (IMiDs) and has shown significant success in both newly diagnosed and relapsed multiple myeloma cases.

  • Bortezomib

    A proteasome inhibitor that can be administered either intravenously or subcutaneously for the treatment of multiple myeloma. It works by blocking the proteasome, a cellular complex that breaks down proteins, leading to the accumulation of proteins in cancer cells and ultimately causing their death. This first-in-class proteasome inhibitor has become a cornerstone of multiple myeloma therapy, particularly effective in combination treatment regimens.

  • Dexamethasone

    A synthetic corticosteroid medication typically taken orally in tablet form, though it can also be administered intravenously. It helps reduce inflammation and suppress the immune system, making it valuable in multiple myeloma treatment by directly killing myeloma cells and enhancing the effects of other anti-myeloma drugs. This medication is commonly used as part of combination therapy protocols in multiple myeloma treatment.

  • Isatuximab

    A monoclonal antibody that can be administered either intravenously or subcutaneously for the treatment of multiple myeloma. It works by targeting the CD38 protein found on the surface of myeloma cells, helping the immune system identify and destroy these cancer cells more effectively. This targeted therapy represents a newer class of treatments for multiple myeloma and has shown promising results when combined with standard therapy regimens.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that produce antibodies. The disease begins when healthy plasma cells in the bone marrow become abnormal and multiply uncontrollably, forming tumors in multiple bones throughout the body. These cancerous cells produce abnormal proteins and interfere with the production of normal blood cells. As the disease progresses, it can weaken bones, cause anemia, reduce the body's ability to fight infections, and affect kidney function. The abnormal plasma cells can crowd out healthy blood cells in the bone marrow and produce excessive amounts of a single type of antibody.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516300-41-00Protocol codeGMMG-HD8/DSMM XIXEstimated enrolment514 patientsSponsorUniversitaetsklinikum Heidelberg AöR

sourced from the EU Clinical Trials Register and site verification

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