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A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

NCT03287908 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-10-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

AMG 701

Subjects will receive IV infusions of AMG 701.

DRUG

Pomalidomide

Subjects will receive oral capsules of pomalidomide.

DRUG

Dexamethasone

Subjects will receive IV injections or oral dexamethasone.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Japan
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03287908 on ClinicalTrials.gov