Terminated/Withdrawn
Sponsor ID
20170122

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 ID
20170122
Clinicaltrials.gov ID
NCT03287908
EUCTIS ID
N/A
EudraCT ID
2017-001997-41

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 701
Type
Interventional
Masking
None (Open Label)
Enrollment
174
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of subjects with dose-limiting toxicities (DLTs)

Timeframe: 28 days

Number of subjects with treatment emergent adverse events (TEAEs)

Timeframe: 60 months

Number of subjects with treatment-related adverse events

Timeframe: 60 months

Number of subjects with disease-related adverse events

Timeframe: 60 months

Number of subjects with clinically-significant changes in vital signs

Timeframe: 48 months

Number of subjects with clinically-significant changes in physical examination measurements

Timeframe: 48 months

Number of subjects with clinically-significant changes in electrocardiogram (ECG) measurements

Timeframe: 48 months

Number of subjects with clinically-significant changes in clinical laboratory tests

Timeframe: 48 months

Secondary Outcome Measures

Pharmacokinetic parameter of AMG 701: Maximum concentration (Cmax)

Timeframe: 12 weeks

Pharmacokinetic parameter of AMG 701: Time of maximum concentration (Tmax)

Timeframe: 12 weeks

Pharmacokinetic parameter of AMG 701: Area under the concentration-time curve (AUC)

Timeframe: 12 weeks

Pharmacokinetic parameter of AMG 701: Steady state concentration (Css)

Timeframe: 12 weeks

Anti-tumor activity: Overall response rate

Timeframe: 48 months

Anti-tumor activity: Best overall response of stringent complete response (sCR)

Timeframe: 48 months

Anti-tumor activity: Best overall response of complete response (CR)

Timeframe: 48 months

Anti-tumor activity: Best overall response of very good partial response (VGPR)

Timeframe: 48 months

Anti-tumor activity: Best overall response of partial response (PR)

Timeframe: 48 months

Anti-tumor activity: Duration of response

Timeframe: 48 months

Anti-tumor activity: Time to response

Timeframe: 48 months

Anti-tumor activity: Progression-free survival

Timeframe: 48 months

Anti-tumor activity: Overall survival

Timeframe: 60 months

Anti-tumor activity: Number of subjects with minimum residual disease negative complete response

Timeframe: 48 months

Pharmacokinetic parameter of AMG 701: Trough concentration (Ctrough)

Timeframe: 12 weeks

Locations

Location
Status
Contact Us
Location
Columbia University Medical Center
New York, NY, United States, 10032
Status
Recruiting
Location
Peter MacCallum Cancer Centre
Melbourne, VIC, Australia, 3000
Status
Recruiting
Location
The Alfred Hospital
Melbourne, VIC, Australia, 3004
Status
Recruiting
Location
Washington University
St. Louis, MO, United States, 63110
Status
Recruiting
Location
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Status
Recruiting
Location
University of Chicago Medical Center - Multiple Myeloma Research Consortium
Chicago, IL, United States, 60637
Status
Recruiting
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