A Study Comparing Treatment With Teclistamab and Talquetamab Versus Daratumumab and Lenalidomide in Patients With Multiple Myeloma After Stem Cell Transplant Who Still Have Detectable Disease

Sponsor
Polish Myeloma Consortium
Study ID
NCT07740486
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Multiple Myeloma (MM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab — DRUG
    Teclistamab is administered as part of combination immunotherapy according to protocol-defined dosing and schedule in participants receiving maintenance treatment for multiple myeloma.
  • Talquetamab — DRUG
    Talquetamab is administered in combination with teclistamab as part of maintenance immunotherapy according to protocol-defined dosing and schedule.
  • Daratumumab (Subcutaneously) — DRUG
    Daratumumab is administered as part of standard maintenance therapy according to protocol-defined dosing and schedule in participants with multiple myeloma.
  • Lenalidomide — DRUG
    Lenalidomide is administered as continuous maintenance therapy according to protocol-defined dosing and schedule in combination with daratumumab.

Study Details

Multiple myeloma is a type of blood cancer that can come back even after effective treatment. After high-dose therapy and autologous stem cell transplantation (ASCT), some patients have no visible signs of disease, but small numbers of cancer cells may still remain in the body. This is called measurable residual disease (MRD). These remaining cells may lead to disease relapse. The purpose of this study is to find out whether a new maintenance treatment can eliminate these remaining cancer cells more effectively than the current standard treatment. More effective maintenance therapy may help reduce the risk of disease progression and improve long-term outcomes for patients. This study, called TiTan, is a phase III, multicenter clinical trial conducted in Poland. It will include 248 adult patients with newly diagnosed multiple myeloma who have undergone ASCT, have no signs of disease progression, but still have detectable MRD. Participants will be randomly assigned (by chance) to one of two treatment groups. Neither the patient nor the doctor can choose the group. In the experimental group, patients will receive two immunotherapy medicines, teclistamab and talquetamab. If MRD becomes undetectable after the protocol-defined period, treatment may be stopped and the patient will continue under observation. In the standard treatment group, patients will receive daratumumab and lenalidomide, which are commonly used maintenance treatments. The duration and adjustments of treatment may depend on MRD results. The main goal of the study is to determine how many patients achieve undetectable MRD after 12 months of treatment together with a complete response to therapy. This will show whether the new treatment is more effective in removing residual cancer cells. The study will also evaluate how long patients live without disease progression, overall survival, treatment safety, and the impact of treatment on patients' daily functioning and quality of life. In addition, researchers will assess whether achieving undetectable MRD leads to better long-term outcomes. Patient safety will be closely monitored throughout the study. Participants will undergo regular medical check-ups, including blood tests, bone marrow tests, and imaging studies. All side effects will be carefully recorded and assessed according to international standards. Patients may withdraw from the study at any time without giving a reason. This non-commercial study aims to improve knowledge about maintenance treatment in multiple myeloma after ASCT and may help support future treatment decisions for patients with this disease.

Key Dates

First listed
Jul 31, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2031
Completion
Apr 30, 2033

Study Design

Enrollment
248 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Tec-Tal)
    Participants receive maintenance therapy with teclistamab in combination with talquetamab. The study evaluates whether maintenance treatment with dual immunotherapy can improve eradication of measurable residual disease in participants with newly diagnosed multiple myeloma who remain MRD-positive after autologous stem cell transplantation. Treatment is administered according to protocol-defined procedures, and participants are followed for assessment of efficacy and safety outcomes.
  • Active Comparator: Arm B (Dara-R)
    Participants receive maintenance therapy with daratumumab and lenalidomide. This treatment regimen represents the comparator maintenance strategy for participants with newly diagnosed multiple myeloma who remain MRD-positive after autologous stem cell transplantation. Treatment is administered according to protocol-defined procedures, and participants are followed for assessment of efficacy and safety outcomes.

Primary Outcome Measure

Proportion of Participants Achieving MRD Negativity With Complete Response [ Time Frame: At Month 12 ]

Central Contacts

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