Morphosys: Keine Ignoranz der Pipeline mehr!

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 Myeloma

Purpose
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 Myeloma

Further 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)