Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT01355705
Brief Summary:
To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.
Detailed Description:
PRIMARY OBJECTIVES
* Establish the maximum tolerated dose (MTD) and toxicity profile for the combination of amrubicin with lenalidomide and dexamethasone in previously treated adult patients with multiple myeloma during Phase I
* Determine the combined rate of complete response (CR) and very good partial response (VGPR) for this combination in this population as defined by the International Myeloma Working Group Uniform Response Criteria (IMWGURC)
SECONDARY OBJECTIVES
* Determine the overall response rate (CR, VGPR and PR)
* Assess additional evidence of ant-tumor activity as measured by duration of response (DOR), progression-free survival (PFS), time to tumor progression (TTP), and overall survival (OS)
Study:
NCT01355705
Study Brief:
Protocol Section:
NCT01355705