A Phase 1/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 Monotherapy, or in Combination with Pomalidomide, with and without Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma (ParadigMM-1B)
Study of Drug in Subjects with Multiple Myeloma
Sponsor: Amgen
Enrolling: Male and Female Patients
IRB Number: AAAR5312
U.S. Govt. ID: NCT03287908
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: You are being asked to take part in this study because you have Multiple Myeloma. This study is being done to learn more about AMG 701 in people with Multiple Myeloma. It will see if AMG 701 is safe and tolerable and whether it causes any side effects. This study will also look at what doses of AMG 701 are safe for people to take and what the effect on Multiple Myeloma is. To find this out, the dose of AMG 701 is gradually increased for each treatment group in the dose exploration part of the study, and any adverse drug reactions that occur while AMG 701 is administered are documented and evaluated by a committee in which all study doctors and Amgen are represented. Only after this committee has confirmed the safety of the investigated dose level may a higher dose be administered to the next group of patients. Once the dose exploration part of the study has been completed up to 75 subjects will be enrolled in the expansion part to be treated at the dose, which has been identified in the dose exploration part.
Investigator
Suzanne Lentzsch, MD
Do You Qualify?
Are you 18 years or older? Yes No
Have you been diagnosed with multiple myeloma? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162