A Phase II Study of Dexamethasone (Decadron), Clarithromycin (Biaxin), and Pomalidomide (CC-4047) for Subjects with Relapsed or Refractory Multiple Myeloma

Study Status

Open to Enrollment

Study Description

This study will evaluate the use of a new drug called pomalidomide, in combination with dexamethasone and clarithomycin, in the treatment of relapsed or refractory multiple myeloma.

Pomalidomide, also called CC-4047, belongs to a group of drugs that can modify or regulate the functioning of the immune system (immunomodulatory drugs). Pomalidomide is chemically similar to thalidomide and lenalidomide, both of which have been approved by the FDA for treatment of multiple myeloma.

The purpose of the study is to determine how well patients respond to treatment. The study will also determine the toxicity (side effects) of the combination, the time to maximum response and the time to disease progression.

Study treatment plan:

  • Pomalidomide daily for days 1-21 of each 28 day cycle
  • Dexamethasone (40mg ) on days 1, 8, 15, 22 of a 28-day cycle
  • Clarithromycin on days 1-28 of a 28 day cycle

All participants will remain on study as long as they are responding to therapy and not experiencing unacceptable side effects. Participants who achieve a stable plateau may be taken off study if eligible to proceed to high dose chemotherapy and autologous stem cell transplantation. Participants will be in the study for up to one year.

Disease Status and/or Stage

Relapsed or Refractory Multiple Myeloma

Sponsor

Weill Cornell Medical College

Key Eligibility

  • Men and women age 18 and older
  • Relapsed or refractory multiple myeloma
  • Must have been treated with lenalidomide and determined to be refractory, resistant or relapsed
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ruben Niesvizky, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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