Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone for the Treatment of MM Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto

About this trial

This is an observational study aiming at collecting efficacy and safety data on the use of SVd outside clinical trials, for the treatment of adult patients with MM who have received 1-3 prior line of therapy.

A minimum of 159 patients is required. Overall study duration is estimated in 36 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age equal to or greater than 18 years old at the time of SVd initiation

Signed informed consent (if applicable).

Diagnosis of symptomatic MM, as defined by the International Myeloma Working Group (IMWG) criteria.

Relapse after one to three lines of therapy.

Disqualifiers

None

Trial population

this study will include patients who will start SVD treatment during the study enrolment period or who received at least one dose of the treatment according to AIFA authorization before the study inclusion date.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

SdV therapy effectiveness in terms of Progression Free Survival

to describe the effectiveness of the use of SVd therapy outside clinical trials in terms of Progression free survival after 12 months from the start of treatment

Time frame
at 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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