Quattro volte al mese (Italian Edition)

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Italian term or phrase: Gary Presto Local time: Date on which this record was first entered in the EudraCT database:. Title of the trial for lay people, in easily understood, i. The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product.

Combination product that includes a device, but does not involve an Advanced Therapy. Patients with Multiple Myeloma. To determine the efficacy of a prolonged treatment with bortezomib twice monthly s. Patient is of a legally consenting age as defined by local regulations. Patient is, in the investigator s opinion willing and able to comply with the protocol requirements.

Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.

Clinical trials

Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time one highly effective method and one additional effective method Highly Effective Methods: Latex condom; Diaphragm; Cervical Cap for 4 weeks prior to beginning study drug therapy, during study drug therapy including dose interruption and for 4 weeks after discontinuation of therapy.

Male patient agrees to use an acceptable method for contraception i. Patient was previously diagnosed with multiple myeloma based on standard criteria.

Patient is relapsed or refractory after one to three lines of treatment and the last one must be a bortezomib-containing regimen, without evidence of progressive disease. Patient had previously received at least 4 cycles of a salvage treatment containing bortezomib, before enrolment, without evidence of progressive disease.

una volta al giorno, tre volte al mese

Patient must be enrolled and start therapy within 45 days from the completion of the last salvage cycle containing Bortezomib. Before the salvage treatment with bortezomib-based regimens, patient must have measurable disease, defined as follows: Patient has the following laboratory values within 14 days before Baseline day 1 of the Cycle 1, before study drug administration: Pazienti maggiorenni come definito dalle norme locali vigenti.

Pazienti che, secondo l'opinione dello sperimentatore i , siano in grado di adempiere alle richieste del protocollo.