MedTrace Logo

Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma

NCT02928029 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-02-26

Study results available
· View outcomes & findings →

Summary

This study will be conducted in 2 parts. The phase 1b part will be an international, phase 1b, open-label, dose-escalation assessment of radium-223 dichloride administered with bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint is to determine the optimal dose of radium-223 dichloride in combination with bortezomib/dexamethasone for the Phase 2 portion of the study.

The phase 2 part will be an international, phase 2, double-blind, randomized, placebo-controlled assessment of radium-223 dichloride versus placebo administered with bortezomib and dexamethasone, in subjects with relapsed multiple myeloma.

Up to 12 subjects in all dose cohorts combined will be treated in the phase 1b part of the study. Up to approximately 100 subjects will be enrolled in the phase 2 part of the study.

Conditions

Interventions

DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Sequential dose escalation in Intravenous (IV) injection

DRUG

Placebo

Matching placebo

DRUG

Bortezomib

Bortezomib is administered subcutaneous (SC) (per Investigator choice ) at 1.3 mg/m2/dose

DRUG

Dexamethasone

Dexamethasone is administered orally at 40 mg

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2019-03-20
Completion
2019-03-20
FDA Drug
Yes

Countries

  • United States
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT02928029 on ClinicalTrials.gov