NCT02516696

BiRd vs. Rd as Initial Therapy in Multiple Myeloma

Lenalidomide and Dexamethasone (Rd) Versus Clarithromycin [Biaxin®] / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2022-06-22
• Completion: 2022-07-22
• First posted: 2015-08-06
• Last updated: 2023-06-05
• Results posted: 2023-06-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study