Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma

What we are studying

This research study for patients with newly diagnosed Multiple Myeloma is looking at the safety and effectiveness of a drug, Daratumumab, when added to a standard of care treatment, Revlimid® (lenalidomide), Velcade® (bortezomib), and dexamethasone (RVd) alone. The study is being done primarily to look at whether or not adding daratumumab to standard of care treatment — Revlimid® (lenalidomide), Velcade® (bortezomib), and dexamethasone (RVd) — will help patients with newly diagnosed Multiple Myeloma achieve a better response after receiving treatment with RVd, with or without daratumumab, and an autologous stem cell transplant (ASCT). A better response is a treatment outcome where there are ? 5% plasma cells in the bone marrow and no evidence of myeloma proteins in your serum or urine by lab testing. The study will examine whether adding daratumumab to RVd treatment affects the effectiveness of treatment, compared to RVd alone. Other assessments of daratumumab study treatment will also be performed, such as the safety and tolerability of the drug, how the drug is used by the body (pharmacokinetics), how the body’s immune system responds to the drug (immunogenicity), and how patients feel while taking the drug (patient reported outcomes, or PRO).

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18 - 70

Eligibility Criteria

  • While you are in the study you must
  • Not take part in any other medical research studies
  • Tell the study doctor about your medical history and new medical conditions or side effects you have during the study
  • Tell the study doctor about any health problems you have during the study
  • Tell the study doctor about any new medicine (including those you get without a prescription) you take during the study
  • Not take any other drugs or remedies unless you inform the study doctor. This includes prescription and over-the-counter drugs (including vitamins and herbs) unless the study doctor approves
  • Come to all study visit appointments
  • Take all medications as prescribed by your study doctor
  • Not get pregnant or cause your partner to become pregnant
  • Not breast feed a child during the study or for up to 3 months after your last dose of study medication
  • Not donate your eggs (ova
  • Oocytes) for reproduction purposes during the study and for up to 3 months after your last dose of study medication
  • Not donate your sperm

What is involved

  • Medical history review
  • Height
  • Chest x-ray
  • Pulmonary function test
  • ECG
  • Physical examination
  • Neurological examination
  • Weight
  • Vital signs
  • Blood draws/tests
  • Questionnaires
  • Bone marrow biopsy/aspirate
  • Follow-Up assessments

Compensation

$53 per visit

Contact Information

Study Coordinator
Suzanne Seth, OCN, CHPN, BSN, MPH
Email
sseth@wakehealth.edu
Phone
336-713-6925
Principal Investigator
Cesar Rodriguez Valdes, 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.