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MUK Nine b: OPTIMUM Treatment Protocol

NCT03188172 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-05-14

No results posted yet for this study

Summary

To determine whether a combination of four novel agents bortezomib(Velcade), lenalidomide (Revlimid), Daratumumab (Darzalex) \& dexamethasone in combination with low-dose cyclophosphamide is sufficiently active in a high risk population of myeloma patients, to take forward into a phase III trial compared to standard treatment.

Conditions

Interventions

DRUG

Cyclophosphamide

Chemotherapy

DRUG

Bortezomib

Chemotherapy

DRUG

Lenalidomide

Chemotherapy

DRUG

Daratumumab

Chemotherapy

DRUG

Dexamethasone

Chemotherapy

DRUG

Melphalan

Chemotherapy

DRUG

Filgrastim

Haematopoietic agent for the stem cell harvest

Sponsors & Collaborators

  • Myeloma UK

    collaborator OTHER

  • Celgene

    collaborator INDUSTRY

  • Janssen, LP

    collaborator INDUSTRY

  • University of Leeds

    lead OTHER

Principal Investigators

  • Martin Kaiser · University of Leeds

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2025-10-01
Completion
2026-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03188172 on ClinicalTrials.gov