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Multiple Myeloma

Anti-CXCR4 (BMS-936564) Alone and in Combination for Relapsed/Refractory Multiple Myeloma (UW11025)
A Phase 1b, Open-label, Multicenter Study of (BMS-936564) in Combination With Lenalidomide (Revlimid) Plus Low-dose Dexamethasone, or With Bortezomib (Velcade) Plus Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Status Conditions Phase Study ID
Closed Multiple Myeloma Phase I UW11025
NCT01359657
Summary

The purpose of this study is to determine 1) the safety and tolerability of multiple intravenous doses of anti-CXCR4 (BMS-936564) as monotherapy and as combination, and 2) the maximum tolerated dose (MTD) of BMS-936564 in combination with Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in subjects with relapsed or refractory multiple myeloma.


Investigator
Pamela Becker, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Subjects must have confirmed diagnosis of multiple myeloma with measurable disease Excluded are subjects with only plasmacytomas, plasma cell leukemia, or non-secretory myeloma.
  • Disease must be assessed within 28 days prior to treatment initiation.
  • Subjects must have evidence of relapsed or relapsed/refractory disease.
  • Subjects must have received at least 2 prior regimens for multiple myeloma.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2.
  • Subjects must have received last treatment (ie, chemotherapy, radiotherapy, biological, immunotherapy or investigational agent [therapeutic or diagnostic]) at least 14 days prior to treatment initiation.
Exclusions (conditions that would prevent participation in this study)
  • A serious uncontrolled medical disorder or active infection.
  • Current or recent (within 3 months) gastrointestinal disease or condition that could impact the absorption of orally-administered drug.
  • Inability to swallow oral medication.
  • Uncontrolled or significant heart disease.
  • Any other malignancy, excluding basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years.
Last Updated
August 21, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.