Carfilzomib + Dexamethasone for Multiple Myeloma

(CarBiRD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Adriana Rossi, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and effectiveness of an investigational new drug called carfilzomib, in combination with dexamethasone in subjects with newly diagnosed multiple myeloma followed by treatment with a combination of drugs clarithromycin (Biaxin®), lenalidomide (Revlimid®) and dexamethasone (Decadron®) \[BiRD\] then lenalidomide alone.

Eligibility Criteria

This trial is for adults with newly diagnosed multiple myeloma who haven't had anti-myeloma therapy recently, except limited corticosteroids. Participants must have measurable disease, be able to perform daily activities at a certain level, take blood clot prevention medication, and comply with the RevAssist® program. Women of childbearing age must test negative for pregnancy and use birth control.

Inclusion Criteria

Participants must have certain test results within a certain range.

I haven't had myeloma treatment in the last 14 days, except for limited corticosteroids.

If subject is a female of childbearing potential (FCBP), she must have a negative pregnancy test and agree to specific birth control measures

Exclusion Criteria

I do not have any infections or health issues that would make this treatment too risky for me.

I am currently pregnant or breastfeeding.

My multiple myeloma cannot be measured by standard tests.

Participant Groups

The study tests carfilzomib combined with dexamethasone in new multiple myeloma patients followed by clarithromycin (Biaxin®), lenalidomide (Revlimid®), and dexamethasone [BiRD] treatment then maintenance with lenalidomide alone to assess safety and effectiveness.

Group I: Car-BiRD Therapy Experimental Treatment 4 Interventions

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\]

Carfilzomib is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Kyprolis for:

• Multiple myeloma

🇪🇺 Approved in European Union as Kyprolis for:

• Multiple myeloma

🇨🇦 Approved in Canada as Kyprolis for:

• Multiple myeloma

🇯🇵 Approved in Japan as Kyprolis for:

• Multiple myeloma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Weill Cornell Medical College New York, NY

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University Lead Sponsor

Onyx Therapeutics, Inc. Industry Sponsor

References