Short summary

The multinational TALTEC investigates if the addition of TALquetamab and TEClistamab to first line treatment improves the response depth in patients with newly diagnosed multiple myeloma (MM). This study, hosted at OPEN, is a sub study evaluating the impact of talquetamab and teclistamab on the patients´ health-related quality of life (HRQL) from the patients' perspective, using patient reported outcome (PRO) data.

Rationale

Great improvements in the treatment of MM have been obtained, but the disease remains incurable, and most patients continuously cycle between treatment remissions and relapses, frequently with more than 10 treatment lines. The best and longest responses are achieved in the first lines of treatment. Achieving minimal residual disease (MRD) negativity in the first line treatment has thus become the most important prognostic factor and indicator of clinical outcome. To achieve an increased MRD, consolidation with Talquetamab and Teclistamab is added to the first line treatment in the TALTEC study. The overall aim of the TALTEC PRO sub study is to evaluate the impact of Talquetamab and Teclistamab consolidation added to first line treatment on the patients´ HRQL in newly diagnosed MM patients eligible for high dose treatment from the patients' perspective using PRO data.

Description of the cohort

The TALTEC study will include 50 newly diagnosed patients with MM eligible for high-dose therapy. Patients will be included from seven hematological departments: three in Denmark, three in Norway, and one in Estonia. All patients included in the TALTEC study will also participate in the PRO sub study.

Data and biological material

Besides PRO data, this sub study includes data on use of any kind of rescue medication that might have an impact on side effects and HRQL. PRO data will be collected using the following questionnaires: the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30), the Functional Assessment of Cancer Therapy - Cognitive (FACT-Cog), and selected items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Collaborating researchers and departments

Department of Hematology, Vejle Hospital

Department of Hematology, Rigshospitalet

Department of Hematology, Oslo

Department of Hematology, St. Olav

Department of Hematology, Stavanger

Department of Hematology, Tallinn