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Comparison of allogeneic stem cell transplantation versus conventional therapy in patients with multiple myeloma who relapsed after first-line therapy

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What is this trial about?

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

This clinical trial focuses on patients with Multiple Myeloma who have experienced disease progression or relapse after initial treatment. The study compares two treatment approaches: allogeneic stem cell transplantation (using stem cells from a donor) versus conventional therapy. The main purpose is to determine which treatment leads to better survival outcomes over a 5-year period.

The treatment options in this study include several medications that work in different ways to fight the disease. These include lenalidomide, pomalidomide, and dexamethasone, which help control the immune system. Other medications used are bortezomib, carfilzomib, and ixazomib citrate, which work by blocking certain cell processes. The study also uses targeted treatments called daratumumab, isatuximab, and elotuzumab, which are antibodies that help the immune system identify and attack cancer cells.

The study will track how well patients respond to treatment by measuring survival time, checking if the disease comes back, monitoring side effects, and assessing quality of life. Patients will be followed for several years to understand the long-term effects of both treatment approaches. The study specifically looks at the development of complications after stem cell transplantation, including a condition called graft-versus-host disease, where the donated cells attack the patient's body.

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

    Initial evaluation and screening

    Your eligibility for the study will be evaluated based on specific criteria, including confirmation of multiple myeloma diagnosis and age requirements (18-65 years, or 66-70 years with specific health conditions)

    A pregnancy test will be required for female participants

    You must have experienced your first relapse or progression after initial therapy

  2. Step 2

    Salvage therapy initiation

    You will receive 3 cycles of salvage therapy

    Your response to the treatment will be evaluated according to medical criteria

    Treatment may include various combinations of medications administered through different methods:

    - Oral medications: pomalidomide, lenalidomide, selinexor, dexamethasone

    - Intravenous medications: isatuximab, daratumumab, carfilzomib, bortezomib

    - Injectable medications: dexamethasone solution

  3. Step 3

    Treatment assignment

    Based on your response to salvage therapy and donor availability, you will be assigned to one of two treatment groups:

    - Stem cell transplantation group

    - Conventional therapy group

  4. Step 4

    Follow-up period

    Your health status will be monitored for 5 years after treatment assignment

    Regular evaluations will assess your response to treatment

    Quality of life assessments will be conducted at years 1, 3, and 5

    Any complications or side effects will be monitored and documented

  5. Step 5

    Study completion

    The study will conclude after the 5-year follow-up period

    Final evaluation of your health status and treatment outcomes will be performed

Who can join the trial?

12 criteria

  • Must have confirmed multiple myeloma (a type of blood cancer affecting plasma cells)
  • Age requirements:
    • Between 18 and 65 years old, or
    • Between 66 and 70 years old with no major health issues (Sorror score = 0) and good physical functioning (ECOG score ≤ 1)
    • Must be experiencing first relapse or disease progression after initial treatment that included:
      • Initial therapy
      • One or two autologous transplants (using patient's own stem cells)
      • Maintenance therapy
      • Can have received maximum one cycle of rescue treatment before joining the study
      • Must have a matching stem cell donor available after 3 cycles of rescue therapy. Donor can be:
        • A fully matched sibling, or
        • An unrelated donor with complete or near-complete tissue match
        • Must show response to treatment (complete response, partial response, or stable disease) after 3 cycles of rescue therapy
        • Female patients must have a negative pregnancy test
        • Must sign an informed consent form

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Patients who have not previously received autologous stem cell transplantation (a procedure where patient's own stem cells are used for treatment)
  • Patients who did not experience disease relapse or progression after first-line therapy
  • Presence of active, uncontrolled infections
  • Severe heart, lung, liver or kidney dysfunction
  • Pregnancy or breastfeeding
  • Unable to provide informed consent
  • Known allergic reactions to medications used in the study
  • Active participation in other clinical trials
  • Psychiatric conditions that may interfere with study compliance
  • History of other cancers in the past 5 years (except for successfully treated non-melanoma skin cancer)
  • Life expectancy less than 6 months due to other medical conditions
  • HIV (Human Immunodeficiency Virus) positive status
  • Active hepatitis B or C infection
  • Poor general health status that prevents safe participation in the study
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Investigated drugs

  • Allogeneic stem cell transplantation (alloSCT)

    is a procedure where stem cells from a matched donor (usually a family member or unrelated donor) are transplanted into the patient. This treatment helps rebuild the patient's immune system and can fight against multiple myeloma cells. The donor's immune cells can recognize and attack the remaining cancer cells in the patient's body.

  • Conventional therapy

    refers to the standard treatment approaches used for multiple myeloma that has returned after initial treatment. This may include various combinations of chemotherapy drugs, targeted therapies, or immunotherapy medications that are commonly used to treat relapsed multiple myeloma. These treatments aim to control the disease and improve survival without using stem cell transplantation.

What is already known about the treatment

Since no specific medications are listed in the provided trial data, I can describe the key therapeutic approach mentioned: Allogeneic Stem Cell Transplantation - A complex medical procedure where healthy blood-forming stem cells from a matched donor are transferred to a patient to replace damaged bone marrow cells. This treatment is used as a salvage therapy for patients with multiple myeloma who have not responded to or relapsed after first-line treatment with autologous stem cell transplantation. The procedure works by introducing new, healthy stem cells that can rebuild the patient's immune system and potentially fight against remaining cancer cells through what's known as the graft-versus-myeloma effect. This therapy belongs to the category of cellular therapies and represents one of the most intensive treatment options available for multiple myeloma patients.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that normally produce antibodies to fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, creating collections of abnormal cells that can form tumors in multiple bones. These cancerous cells produce large amounts of abnormal proteins instead of useful antibodies. The disease typically affects multiple bones throughout the body, particularly in the spine, skull, pelvis, and ribs. As the disease progresses, it can interfere with the production of normal blood cells and can weaken the bones.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510590-14-00Protocol codeAlloRelapseMMStudyEstimated enrolment400 patientsSponsorUniversity Medical Center Hamburg-Eppendorf

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).