Morphosys hat jetzt den
MOR202 bei clinicalTrials.gov angemeldet:
http://clinicaltrials.gov/ct2/show/NCT01421186?term=morphosy…A Phase I/IIa Study of Human Anti-CD38 Antibody MOR03087 in Relapsed/Refractory Multiple MyelomaPurpose
This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti CD38 antibody MOR03087 in adult subjects with relapsed/refractory multiple myeloma as monotherapy and in combination with standard therapy in patients with relapsed/refractory multiple.
Phase I
Phase II
Study Type: Interventional
Study Design:
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:
A Phase I/IIa, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD38 Antibody MOR03087 as Monotherapy and in Combination With Standard Therapy in Subjects With Relapsed/Refractory Multiple MyelomaFurther study details as provided by MorphoSys AG:
Primary Outcome Measures: •1. Determination of maximum tolerated dose and / or recommended dose [ Time Frame: after all patients have completed the first 2 cycles of treatment (up to 20 weeks) ] [ Designated as safety issue: Yes ]
•2. Safety will be evaluated by assessing adverse events, clinical lab data and vital signs [ Time Frame: every 2 to 4 weeks ] [ Designated as safety issue: Yes ]
•3. Number of participants who develop anti-MOR03087 antibodies as a measure of immunogenicity [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures: •1. Pharmacokinetics of MOR03087 (C max, t max, t 1/2, CL, AVC) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
•2. Overall response rate based on standard response criteria, change from baseline in serum M protein levels [ Time Frame: monthly (approximately 1 year) ] [ Designated as safety issue: No ]
Estimated Enrollment: 82
Study Start Date: July 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Thread abonnieren
