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Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients

NCT03792763 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-02-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]

Administration every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM

DRUG

Placebo 1.7 ml Subcutaneous Solution

Administration every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Assign Data Management and Biostatistics GmbH

    collaborator OTHER

  • Arbeitsgemeinschaft medikamentoese Tumortherapie

    lead OTHER

Principal Investigators

  • Heinz Ludwig, MD · Wilheminenspital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2023-09-14
Completion
2023-09-14

Countries

  • Austria
  • Germany
  • Israel

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792763 on ClinicalTrials.gov