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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT03375567
Brief Summary:
The primary objective of this study is to compare the detection rate of residual/refractory disease based on standard bone marrow biopsy versus guided myeloma lesion biopsy after induction therapy with carfilzomib, lenalidomide and dexamethasone regimen.
Detailed Description:
Carfilzomib, lenalidomide and dexamethasone (CRD) combination therapy is generally associated with high response rates. The expectation is that induction therapy with CRD will result in responses within the myeloma lesions. Extrapolating from the published experience on standard bone marrow response rates with CRD regimen, it is predicted that guided biopsy of myeloma lesions will reveal VGPR/CR/nearCR rate up to 50%. Further, it can be hypothesized that myeloma lesion biopsy will increase the detection rate of residual/refractory disease by about 20%, as compared with standard bone marrow evaluation. Thus, it is expected that myeloma lesion biopsy response rate may be discordant from the standard bone marrow response rate. The identification of patients with large residual disease burden in the myeloma lesions will indicate the need for further salvage therapy. Based on this, it is expected that advanced imaging with guided myeloma lesion biopsy will result in significantly improved response assessment strategy after induction therapy, and will allow better selection of patients prior to autologous stem cell transplant.
Study:
NCT03375567
Study Brief:
Protocol Section:
NCT03375567