Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-31 @ 11:40 PM
Study NCT ID:
NCT03475628
Status:
UNKNOWN
Last Update Posted:
2018-03-23
First Post:
2018-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Daratumumab Monotherapy on Bone Parameters in Patients With Relapsed and /or Refractory Multiple Myeloma
Sponsor:
Hellenic Society of Hematology
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Non-comparative, Open-label, Phase II Study to Evaluate the Effects of Daratumumab Monotherapy on Bone Parameters in Patients With Relapsed and /or Refractory Multiple Myeloma Who Have Received at Least 2 Prior Lines of Therapy, Including Lenalidomide and a Proteasome Inhibitor
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REBUILD
Brief Summary:
The purpose of this study is to evaluate the effects of daratumumab monotherapy on bone disease in patients with relapsed/refractory MM who have received at least 2 prior lines of therapy, including lenalidomide and a PI.
Detailed Description:
This is a prospective, multicenter, non-comparative, open-label Phase II study. Daratumumab will be administered according to approved label. Approximately 57 subjects located in Greece will be enrolled in the study.
Patients shall receive treatment until disease progression, physician decision, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). Survival status and data of subsequent anti-myeloma treatment will be collected post-treatment.
Primary and secondary variables related to bone disease markers will be evaluated every other cycle of therapy. Disease evaluations will occur monthly and consist mainly of measurements of myeloma proteins. Other parameters may include bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin, and β2- microglobulin and albumin. Assessment of myeloma response and disease progression will be conducted in accordance with the modified IMWG response criteria
Patients shall receive treatment until disease progression, physician decision, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). Survival status and data of subsequent anti-myeloma treatment will be collected post-treatment.
Primary and secondary variables related to bone disease markers will be evaluated every other cycle of therapy. Disease evaluations will occur monthly and consist mainly of measurements of myeloma proteins. Other parameters may include bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin, and β2- microglobulin and albumin. Assessment of myeloma response and disease progression will be conducted in accordance with the modified IMWG response criteria
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: