Last updated on February 2020

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


Brief description of study

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.

Detailed Study Description

All patients will be randomized in a 1:1 ratio to receive:

ARM A:

Bortezomib (V):

  • 1.3 mg/m2 subcutaneously on days 1, 4, 8, 11, 22, 25, 29 and 32 in cycles 1-4;
  • 1.3 mg/m2 subcutaneously on days 1, 8, 22 and 29 in cycles 5-9.

Melphalan (M):

  • 9 mg/m2 orally on days 1, 2, 3 and 4 of each cycle.

Prednisone (P):

  • 60 mg/m2 orally on days 1, 2, 3 and 4 of each cycle. Each cycle is to be repeated every 42 days. Duration: Maximum 9 therapy cycles can be performed. After 9 cycles, patients will be observed until progression disease or the start of a new line of therapy.

ARM B:

Lenalidomide (R):

  • 25 mg orally on days 1-21 of each cycle.

Dexamethasone (d):

  • 40 mg orally on days 1, 8, 15 and 22 of each cycle. Each cycle is a 28-day cycles. Duration: patients will receive treatment until any sign of progression or intolerance.

Clinical Study Identifier: NCT03829371

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