Terminated/Withdrawn
Sponsor ID
20200446

A Study of Subcutaneous (SC) AMG 701 in Participants with Relapsed or Refractory Multiple Myeloma (RRMM)ProxiMMity-1

Sponsor ID
20200446
Clinicaltrials.gov ID
NCT04998747
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

A study to evaluate the safety and tolerability of subcutaneous (SC) AMG 701 in participants with relapsed or refractory multiple myeloma (RRMM) to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)

Additional Study Details

Phase
Phase 1
Product
AMG 701
Type
Interventional
Masking
None (Open Label)
Enrollment
0
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of participants who experience dose-limiting toxicities (DLTs)

Timeframe: 28 days

Number of participants who experience one or more treatment-emergent adverse events (TEAEs)

Timeframe: up to approximately 9 months

Number of participants who experience one or more treatment-related TEAEs

Timeframe: up to approximately 9 months

Number of participants with abnormal changes in vital signs

Timeframe: up to approximately 9 months

Number of participants with abnormal changes in electrocardiograms (ECGs) findings

Timeframe: up to approximately 9 months

Number of participants with abnormal changes in clinical laboratory tests

Timeframe: up to approximately 9 months

Secondary Outcome Measures

Maximum serum concentration (Cmax) of AMG 701

Timeframe: up to approximately 8 months

Time to maximum concentration (Tmax) of AMG 701

Timeframe: up to approximately 8 months

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

Timeframe: up to approximately 8 months

Minimum concentration over the dosing interval (Ctrough) of AMG 701

Timeframe: up to approximately 8 months

Incidence of anti-AMG 701 antibody formation

Timeframe: up to approximately 9 months

Overall response (OR)

Timeframe: up to approximately 8 months

Best overall response (BOR)

Timeframe: up to approximately 8 months

Time to response

Timeframe: up to approximately 8 months

Duration of response (DOR)

Timeframe: up to approximately 8 months

Progression-free survival (PFS)

Timeframe: up to approximately 3 years

Overall survival (OS)

Timeframe: up to approximately 3 years

Locations

No locations found.