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.
Documented diagnosis of MM as per IMWG diagnostic criteria.
Newly diagnosed patients who have completed a single or tandem autologous stem cell transplant after receiving quadruplet induction (containing an anti-CD38 antibody, an immunomodulatory drug, and a proteasome inhibitor). Up to 2 cycles of post-ASCT consolidation are acceptable.
Patients must have received high-dose chemotherapy and a first ASCT within 12 months from the initiation of induction therapy.
Patients must be within 6 months of their most recent ASCT, or within 7 months for patients who received consolidation therapy.
Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI CTCAE Version 5.0.
COPD with a FEV1 <50% of predicted normal. Note that FEV1 testing is required for participants with known or suspected of having COPD or asthma and participants must be excluded if FEV1 <50% of predicted normal.
Severe persistent asthma within the past 2 years (see Appendix x[DS2.1] [for severity of Asthma]), uncontrolled asthma of any classification. Note that FEV1 testing is required for participants known or suspected asthma and participants must be excluded if FEV1 <50% of predicted normal.
CNS involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
Parallel
Teclistamab
DrugTeclistamab is administered as part of combination immunotherapy according to protocol-defined dosing and schedule in participants receiving maintenance treatment for multiple myeloma.
Talquetamab
DrugTalquetamab is administered in combination with teclistamab as part of maintenance immunotherapy according to protocol-defined dosing and schedule.
Daratumumab (Subcutaneously)
DrugDaratumumab is administered as part of standard maintenance therapy according to protocol-defined dosing and schedule in participants with multiple myeloma.
Lenalidomide
DrugLenalidomide is administered as continuous maintenance therapy according to protocol-defined dosing and schedule in combination with daratumumab.
Proportion of Participants Achieving MRD Negativity With Complete Response
The proportion of participants achieving measurable residual disease negativity at a sensitivity level of 10\^-5 together with complete response, assessed according to International Myeloma Working Group (IMWG) criteria at the specified timepoint.
Progression-Free Survival
Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
Change From Baseline in Global Health Status and Functional Scales Assessed by EORTC QLQ-C30
Mean change from baseline in global health status and functional scales assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Change From Baseline in Multiple Myeloma-Specific Quality of Life Assessed by EORTC QLQ-MY20
Mean change from baseline in multiple myeloma-specific quality of life assessed using the European Organisation for Research and Treatment of Cancer Multiple Myeloma Module (EORTC QLQ-MY20).
Overall Survival
Time from randomization to death from any cause.
Click on the lead sponsor to view all of their trials.
Polish Myeloma Consortium
Lead sponsor
Medical Research Agency, Poland
Collaborator
Johnson & Johnson
Collaborator
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