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

3 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Asklepios Klinik St George Hamburg Germany
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Ugttljlngf Mmevbva Cqfpjh Hqasvbyreejqpzbzo Hamburg Germany
Uwrujkypjhpurlgaspixj Etied Axq Essen Germany
Ucqoptqnisvgctfhdhyey Auxjcgay Augsburg Germany
Ucrokralvsocbkpjbbbfw Dpsphamnewe Ahu Duesseldorf Germany
Utsjiuobenqjbfohgwxuv Mdakravx Aer Munster Germany
Gvlsmz Urzivqcvya Fevxlzsmq Frankfurt Germany
Kqunakcm dge Ukjikbhznlcj Mtiqdlwz Aac Munich Germany
Upaxahngaihnhwonrlkkx Wwzculqfj Ayq Wuerzburg Germany
Mgzmwasxpxmdcnbwqtmyfdgwjx Hqxbglhrzvvhfyho Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
13.10.2022

Trial locations

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.

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 ID:
2024-510590-14-00
Protocol code:
AlloRelapseMMStudy
NCT ID:
NCT05675319
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study of etentamig and daratumumab compared to daratumumab, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma not eligible for transplant

    Recruiting

    4 1 1 1
    France Norway Spain
  • A study testing etentamig alone or with drug combinations in adult patients with multiple myeloma to assess safety and changes in disease activity

    Recruiting

    1 1 1 1
    Norway