Phase 1b/2 study testing radium-223 dichloride in relapsed multiple myeloma

What we are studying

The main goals of this study are to look at the safety of the combination of the study drug radium-223 dichloride plus bortezomib and dexamethasone and to determine the optimal dose of radium-223 dichloride to be used in combination with bortezomib and dexamethasone. Radium-223 dichloride has been approved in some countries for treatment of patients with prostate cancer with bone metastases, but has not been approved yet in patients with multiple myeloma. Radium-223 dichloride is a radioactive drug, that is administered through the vein and that is taken up by bones after it is injected into the body. It works by giving off radioactivity, which is thought to kill the tumor cells that have spread to the bone. Radium-223 dichloride mainly releases a type of radioactivity that travels a very short distance. As a result, most of the effects of the drug are limited to the bones, which is the main location where your multiple myeloma has caused lesions. The amount of radioactivity in a dose of radium-223 dichloride is measured in kilo Becquerel (kBq). Each patient gets a radium-223 dichloride dose that is based on their weight measured in kilograms (kg). The dose of radium-223 dichloride is measured based on a standardized radium sample. The dose of radium-223 dichloride that is approved for other indications by the FDA and health authorities in Europe is 55 kBq per kilogram of weight. Each dose of radium-223 dichloride is administered through the vein, once every 6 weeks (a “dose”), for up to six doses. This study is an open label study where all the patients will receive bortezomib, dexamethasone and radium-223 dichloride. The dose of radium-223 dichloride received will depend on the group that you are enrolled to. Bortezomib is an approved cancer therapy and belongs to a class of medicines known as proteasome inhibitors. It is approved for the treatment of patients with multiple myeloma, typically used in combination with dexamethasone, another anti-myeloma drug that is also given in this study.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Subjects must have received at least 1 and not more than 3 previous lines of treatment and have had a response to treatment
  • Subjects must have had progressive disease following the last multiple myeloma treatment
  • Subjects must have ?1 bone lesion identifiable by x-ray
  • CT Scan
  • PET-CT Scan
  • Or magnetic resonance imaging (MRI)
  • Females cannot be pregnant

What is involved

  • Physical exams
  • ECG
  • Blood draws for labs
  • Disease assessments
  • Bone marrow biopsy
  • Questionnaires
  • Skeletal survey
  • Administration of bortezomib and dexamethasone
  • Administration of Radium-223 dichloride or placebo

Compensation

Subjects will received $50.00 per visit to cover travel expenses.

Contact Information

Study Coordinator
Suzanne Seth, RN
Email
sseth@wakehealth.edu
Phone
336-713-6925
Principal Investigator
Cesar Rodriguez, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.