Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients
Status:
Active, not recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
This is a randomized, 2-arm phase II, placebo-controlled, multi-center study, where the
investigators aim to evaluate whether the reported benefits of denosumab, delay of SRE and
decrease in myeloma growth promotion, reduce the risk of progression of high-risk SMM and of
early 'SLiM CRAB' myeloma into active, symptomatic CRAB positive myeloma or serological
progression. In addition, tolerability of long-term treatment will be assessed.
Phase:
Phase 2
Details
Lead Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators:
Amgen Assign Data Management and Biostatistics GmbH