- Recruiting
NCT03287908: Phase 1/2: AMG 701 Montherapy With Pomalidomide +/- Dex in Relapsed Multiple Myeloma
Updated: Jul 15, 2022
Anti-BCMA x Anti-CD3 BiTE
A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will include a sequential dose exploration part to identify the RP2D of AMG 701 in combination with pomalidomide, with and without dexamethasone (AMG 701-P+/-d). Phase 2 will consist of the dose-expansion part to gain further efficacy and safety experience with AMG 701 monotherapy in adult subjects with RRMM.
A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Sponsor
Amgen
ClinicalTrials.gov Identifier: NCT03287908
Official Title: 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)
First Posted : September 19, 2017
Click here for details on ClinicalTrials.gov
Other Study ID Numbers: 20170122
2017-001997-41 ( EudraCT Number )
pavurutamab - anti-BCMA/CD3 BiTE antibody AMG 701
AMG 701
Pavurutamab (Code C147028)
AMG 701
AMG-701
AMG701
Anti-BCMA x Anti-CD3 BiTE AMG 701
Anti-BCMA/CD3 BiTE Antibody AMG 701
BCMA/CD3-directed Bispecific T-cell Engager Antibody AMG 701
Bispecific T-cell Engager Antibody AMG 701
BiTE Antibody AMG 701
Pavurutamab
PAVURUTAMAB
The immunomodulatory drugs lenalidomide and pomalidomide enhance the potency of AMG 701 in multiple myeloma preclinical models
Blood Adv. 2020 Sep 8
181 A Phase 1 First in Human (FIH) Study of AMG 701, an Anti-B-Cell Maturation Antigen (BCMA) Half-Life Extended (HLE) BiTE® (bispecific T-cell engager) Molecule, in Relapsed/Refractory (RR) Multiple Myeloma (MM)
Abstract, 62nd ASH Annual meeting
Dec 5-8, 2020
Locations
United States, Arizona
United States, Arkansas
United States, Florida
United States, Georgia
United States, Illinois
United States, Massachusetts
United States, Minnesota
United States, Missouri
United States, New Jersey
United States, New York
United States, North Carolina
United States, Texas
United States, Utah
United States, Wisconsin
Australia, Queensland
Australia, Victoria
Asia
Japan
Canada, Ontario
Canada, Quebec
Europe
Germany
Netherlands