• Recruiting

NCT03287908: Phase 1/2: AMG 701 Montherapy With Pomalidomide +/- Dex in Relapsed Multiple Myeloma

Updated: Jul 15

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

amg 701

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

Click here for details

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)

Click here for details

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


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