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Phase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in elderly patients in 1st relapse or primary refractory after first line therapy for multiple myeloma.

Phase I:-To determine the maximum tolerated dose (MTD) and recommended phase II dose level (RDL) of Bortezomib administered once weekly, and of Lenalidomide administered for 3 weeks when combined with Dexamethasone in a 28-days schedule.Phase II:-To…

An Open-Label, Phase Ib, Dose*Escalation Study of the Safety and Pharmacology of the Anti-CD40 Monoclonal Antibody SGN-40 Administered in Combination with Bortezomib (Velcade®, PS-341) in Patients with Relapsed or Refractory Multiple Myeloma.

The primary objective of the study is to determine the MTD (Maximally Tolerated Dose) of SGN-40 from among three possible dose levels when combined with a standard dose of bortezomib and to determine the safety and adverse event profile for…

Effects of bortezomib on bone turnover during treatment of relapsed multiple myeloma: a pilot study of quantitative in-vivo monitoring.

1. The accurateness of the imaging techniques will be evaluated for quantitatively measuring in-vivo and on-site bone turnover in this specific category of patients, i.e. patients with myeloma bone disease.Bone turnover will be measured using * in…

An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

The primary objective is to compare the overall response rate ORR(CR+PR), after 4 cycles, of subcutaneously (SC) administered VELCADE tointravenously (IV) administered VELCADE in patients with previouslytreated multiple myeloma.The secondary…

Randomized phase III trial in elderly patients with previously untreated symptomatic Multiple Myeloma comparing MP-Thalidomide (MP-Thal) followed by thalidomide maintenance versus MP-Lenalidomide (MP-Len) followed by maintenance with lenalidomide

To compare efficacy, safety and quality of life of MP-Thal followed by thalidomide maintenance versus MP-Len followed by maintenance with lenalidomide