BiRd vs. Rd as Initial Therapy in Multiple Myeloma

Status Terminated

Clinical Trial 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.

Clinical Trial Description

This research study is for men and women with newly diagnosed, previously untreated multiple myeloma. The purpose of this study is to observe the how well the different combinations of study drugs work as therapy for patients with newly diagnosed, transplant ineligible, previously untreated multiple myeloma. The study will be done in two arms: BiRd Arm: - Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle - Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle - Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle Rd Arm: - Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle - Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle Subjects will be treated in 28-day cycles and may continue treatment as long as they are responding to therapy and not experiencing unacceptable side effects or disease progression. There will be an evaluation at the end of each cycle. Participants will be in the study until disease progression or unacceptable toxicity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02516696
Study type	Interventional
Source	Weill Medical College of Cornell University
Contact
Status	Terminated
Phase	Phase 3
Start date	February 2016
Completion date	July 22, 2022

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See also
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BiRd vs. Rd as Initial Therapy in Multiple Myeloma — BiRd vs Rd

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms