NCT03934684

Study to Evaluate Safety Tolerability & Efficacy of Kyprolis (Carfilzomib) in Relapsed or Refractory Multiple Myeloma

Post-marketing Phase 4 Study to Evaluate Safety, Tolerability, and Efficacy of Kyprolis® (Carfilzomib) in Indian Patients With Relapsed or Refractory Multiple Myeloma: A Prospective, Open-label, Non-comparative, Multicenter Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To characterize safety associated with the use of Kyprolis under the locally approved label.

Detailed description

Kyprolis® (K; carfilzomib) was approved in India on 17 January 2017 as a prescription medication in combination with dexamethasone (Kd) or with lenalidomide (Revlimid®) plus dexamethasone (KRd) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) following 1 to 3 prior lines of therapy. This non-comparative, interventional phase 4 study is designed to fulfil the post-marketing requirement to assess safety, tolerability, and efficacy of Kyprolis on Indian subjects with RRMM as per the locally approved label.

Conditions

• Relapsed Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Drug: Carfilzomib + Dexamethasone	Drug: Carfilzomib + Dexamethasone * Carfilzomib will be administered as a 30-minute infusion. * Dexamethasone will be taken by mouth or intravenously.
DRUG	Drug: Carfilzomib + Lenalidomide + Dexamethasone	Drug: Carfilzomib + Lenalidomide + Dexamethasone * Carfilzomib will be administered as a 10 minute infusion. * Lenalidomide will be taken orally. * Dexamethasone will be taken by mouth or intravenously.

Timeline

• Start date: 2019-09-16
• Primary completion: 2023-03-23
• Completion: 2025-06-27
• First posted: 2019-05-02
• Last updated: 2025-08-06
• Results posted: 2024-01-02

Locations

17 sites across 1 country: India

Regulatory

• FDA-regulated drug study