MedTrace Logo

GEM-CLARIDEX: Ld vs BiRd

NCT02575144 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2022-02-01

No results posted yet for this study

Summary

This phase III study, open-label, randomized study investigating lenalidomide and dexamethasone with and without biaxin in subjects with newly diagnosed, previously untreated MM. Eligible subjects will be randomized in a 1:1 ratio to receive a regimen consisting of either biaxin, lenalidomide, and low-dose dexamethasone (BiRd arm), or lenalidomide and low-dose dexamethasone (Rd arm). 306 patients will be included (50% in Spain (153) and 50% in the USA (153)

Conditions

Interventions

DRUG

Clarithromycin

500mg PO twice daily on days 1-28 for a 28-day cycle

DRUG

Lenalidomide

25mg PO daily on days 1-21 of a 28-day cycle for patients with a calculated creatinine clearance of \>60 cc/min

DRUG

Dexamethasone

40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle

Sponsors & Collaborators

  • Cabyc, S.L.

    collaborator INDUSTRY

  • PETHEMA Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Spain

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 NCT02575144 on ClinicalTrials.gov