Dynamic frailty-tailored therapy for elderly patients with newly diagnosed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility and benefits of a dynamic frailty-tailored therapy specifically designed for elderly patients with newly diagnosed multiple myeloma (NDMM). It recognizes that frailty is a dynamic condition that affects treatment outcomes and aims to adjust therapy based on the patient's current fitness and frailty status throughout the treatment course. By incorporating real-life practices and focusing on the unique needs of frail patients, the study seeks to improve treatment tolerability and overall outcomes. The intervention includes the use of daratumumab-based regimens as part of the treatment strategy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult males and females aged ≥65 years who were either transplant-ineligible or had no intent for immediate transplant;
* Subject must have documented multiple myeloma as defined by the criteria below:

Monoclonal plasma cells in the bone marrow 10% or presence of a biopsy-proven plasmacytoma;

Measurable disease as defined by any of the following:

* Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
* IgA multiple myeloma: serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
* Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.

  * Has not had prior systemic therapy for multiple myeloma;
  * The functional reserve of the organs can withstand systemic therapy;
  * Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.

Exclusion Criteria:

* There are active systemic viral, fungal, or bacterial infections that require systemic anti-infective treatment;
* Severe organ dysfunction (New York Heart Association class III and IV or transaminases ≥5 normal level, except those caused by cardiac and hepatic amyloidosis secondary to MM)
* Patients with prior history of hematologic or solid tumors treated with radiotherapy or chemotherapy(except ≥5 years);
* Patients who currently have hematologic tumors or solid tumors that require radiotherapy or chemotherapy;
* Non-signation of informed consent.

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.