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

Clinical Trial Details

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.

Key Eligibility:

  • Men and women >65 years at the time of signing the consent form
  • Confirmed diagnosis of multiple myeloma that has never before been treated
  • No prior anti-myeloma treatment therapy within 14 days prior to initiation of study treatment
  • Subject has no prior history of other malignancies unless disease free for >5 years
  • Subject has not had a myocardial infarction within 6 months prior to enrollment
  • Detailed eligibility reviewed when you contact the study team

Contact

Linda Tegnestam
lit2011@med.cornell.edu
(212) 746-1480

Primary Investigator

Ruben Niesvizky, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1411015662

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Drug/Device

Drug

Study Type