BT062 in combination with lenalidomide/dexamethasone in patients with multiple myeloma (clinicaltrials.gov) - Jul 11, 2012 - P1/2, N=49; Not yet recruiting; New P1 trial
New trial • Multiple Myeloma
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This study is not yet open for participant recruitment.
Verified July 2012 by Biotest Pharmaceuticals Corporation
First Received on March 8, 2012. Last Updated on July 11, 2012 History of Changes
Sponsor: Biotest Pharmaceuticals Corporation
Collaborator: Biotest
Information provided by (Responsible Party): Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01638936
Purpose
The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.
Condition
Multiple Myeloma
Intervention
Drug: BT062 , intravenous administration
Phase
Phase 1
Phase 2
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
Resource links provided by NLM:
Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Lenalidomide
U.S. FDA Resources
Further study details as provided by Biotest Pharmaceuticals Corporation:
Primary Outcome Measures:
Determination of optimal dose of BT062 (Phase I part) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The Phase I part will follow a standard dose escalation design with at least 3 patients per dose level to define optimal dose of BT062 in combination with lenalidomide/dexamethasone. Optimal dose will be defined by dose limiting toxicities (DLT) observed during Cycle 1 (28 days).
Evaluation of response (Phase IIa part) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Response to treatment with optimal dose of BT062 (defined in Phase I part) in combination with lenalidomide/dexamethasone will be evaluated at baseline and at start of each Cycle (every 28 days). Response evaluation will be primarily based on assessment of M-protein and serum free light chains. If clinically required bone marrow analysis, plasmacytoma evaluation, and sketetal survey will be performed.
Secondary Outcome Measures:
Qualitative and quantitative toxicities of BT062 in combination with lenalidomide/dexamethasone [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Safety will be assessed at each visit by incidence of adverse events and by clinically significant changes in the patients physical examination, vital signs, and clinically laboratory results
Pharmacokinetics (Cmax, half-life, AUC) of BT062 in combination with lenalidomide/dexamethasone [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Pharmacokinetic parameters will be assessed from plasma by measuring intact BT062 and free maytansinoid (DM4)
Assessment of Time To Event end points [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Based on the response evaluation, the following Time To Event end points will be evaluated: Time To Progression, Progression Free Survival, Time To Next Treatment, Duration Of Response, Overall survival.
Estimated Enrollment: 49
Study Start Date: July 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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