STUDY COMPARING TWO STANDARD TREATMENTS IN AUTOLOGOUS STEM CELL TRANSPLANTATION INELIGIBLE POPULATION AFFECTED BY MULTIPLE MYELOMA

• Status: Recruiting
• Trial end date: 2025-01-03

Summary

Multiple myeloma (MM) is a neoplastic disease deriving from an abnormal proliferation of monoclonal plasma cells in the bone marrow. The survival of MM patients varies from less than 6 months to more than 10 years depending on the stage of disease at diagnosis and prognostic factors. Three current standard treatments are approved for elderly or younger patients with significant comorbidities not eligible for autologous stem cell transplantation (ASCT): bortezomib-melphalan-prednisone (VMP), melphalan-prednisone- thalidomide (MPT) and lenalidomide with low-dose dexamethasone (Rd).

The consistent fraction of elderly patients with cancer and co-morbidities are at increased risk of developing frailty (the emergent geriatric syndrome), as well as physical and cognitive decline, with negative effect on nutrition and lifestyle, and eventually on responsiveness to and efficacy of treatments.

A frailty scale was recently described that categorized patients with MM as fit, intermediate or frail based on age, comorbidities, and physical and cognitive functioning. The frailty score was a predictor of death, progression of the disease, toxicity and drug discontinuation.

In this project, the investigators will compare available first line standard treatments, the triplet VMP versus the doublet Rd, in an unselected population of patients ≥ 65 years affected by MM in every day clinical practice. In the last decade, many novel and expensive drugs have been approved for this disease, yet the general older population is not adequately represented in validating trials. Nevertheless, the results and treatments derived from those trials have often been applied to the older population, with a high risk to produce a negative impact on patient functional capacity and ability to carry out daily tasks, cognitive function, depression status, nutritional condition, social situation/capability to stay at home and finally affecting their quality of life (QoL) and OS. The main aim of the project is to evaluate the best initial treatment for elderly MM patients and to compare benefits, risks, QoL and costs of currently available, standard treatments according to the frailty profile.

• Phase: Phase 4

Details

• Lead Sponsor: University of Turin, Italy
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone acetate; Lenalidomide; Melphalan; Prednisone; Thalidomide