Study identification

PURI

https://redirect.ema.europa.eu/resource/46723

EU PAS number

EUPAS37838

Study ID

46723

Official title and acronym

Comprehensive Analysis of Clinical Parameters That May Inform the Choice of Dose Regimen for Carfilzomib 20/27mg/m2 or 20/56mg/m2 With and Without Dexamethasone (20200381)

DARWIN EU® study

No

Study countries

Australia
Austria
Belgium
Brazil
Bulgaria
Canada
China
Czechia
Denmark
Finland
France
Germany
Hungary
Israel
Italy
Japan
Korea, Republic of
Netherlands
New Zealand
Norway
Poland
Romania
Russian Federation
Serbia
Slovakia
Spain
Sweden
Taiwan
Thailand
Türkiye
Ukraine
United Kingdom
United States

Study description

The aim of this study is to pool data from 13 Amgen-sponsored clinical trials to describe the benefit-risk profile of each carfilzomib (K) regimen based on the clinical parameters associated with efficacy and safety outcomes of subjects treated with one of four different dosing regimens to inform the choice of carfilzomib regimen. The dosing regimens of carfilzomib include a therapeutic dose of 27mg/m2 or 56mg/m2, each as monotherapy or in combination with dexamethasone (K27, K56, Kd27, Kd56). The study population is 1817 subjects with relapsed or refractory multiple myeloma (RRMM), aged 18 and above, who received consistent twice-weekly K treatment with K27, Kd27, K56, or Kd56 via an Amgen-sponsored clinical trial.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol

EUPAS37838-38139

English (1.27 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable