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BiRd vs. Rd as Initial Therapy in Multiple Myeloma

NCT02516696 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-06-05

Study results available
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Summary

This is a randomized, open-label, phase III study to investigate the efficacy of combination therapy with an induction phase utilizing a combination clarithromycin (Biaxin®), lenalidomide (Revlimid®), dexamethasone (Decadron®), in multiple myeloma patients who are newly diagnosed and require treatment when compared to patients who receive lenalidomide and dexamethasone alone.

Conditions

Interventions

DRUG

Clarithromycin

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

DRUG

Lenalidomide

25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle

DRUG

Dexamethasone

20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Jorge Monge, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2022-06-22
Completion
2022-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02516696 on ClinicalTrials.gov