Phase I and pharmacokinetic study of romidepsin in patients with cancer and hepatic dysfunction: A national cancer institute organ dysfunction working group study

RM Connolly, E Laille, U Vaishampayan, V Chung… - Clinical Cancer …, 2020 - AACR
Purpose: Romidepsin dosing recommendations for patients with malignancy and varying
degrees of hepatic dysfunction was lacking at the time of regulatory approval for T-cell …

Bortezomib for the treatment of previously untreated multiple myeloma

A Romano, C Conticello, F Di Raimondo - Immunotherapy, 2013 - Future Medicine
Management of multiple myeloma (MM) has been drastically changed in the last 10 years
thanks to the introduction of novel agents, which, combined with the backbone of classical …

Pharmacokinetics of carfilzomib in patients with advanced malignancies and varying degrees of hepatic impairment: an open-label, single-arm, phase 1 study

J Brown, R Plummer, TM Bauer, S Anthony… - … Hematology & Oncology, 2017 - Springer
Background Carfilzomib is approved in the United States and Europe for treatment of
relapsed or refractory multiple myeloma (MM). This study evaluated pharmacokinetics (PK) …

Lenalidomide, bortezomib, and dexamethasone (RVD) regimen for multiple myeloma

AP Punke, JA Waddell… - Hospital Pharmacy, 2017 - journals.sagepub.com
The complexity of cancer chemotherapy requires pharmacists be familiar with the
complicated regimens and highly toxic agents used. This column reviews various issues …

Pharmacodynamics and pharmacokinetics of proteasome inhibitors for the treatment of multiple myeloma

M Baljevic, RZ Orlowski - Expert opinion on drug metabolism & …, 2019 - Taylor & Francis
Introduction: Multiple myeloma (MM) is the second most commonly diagnosed hematologic
malignancy and has an increasing incidence and prevalence globally, and proteasome …

The use of novel agents in multiple myeloma patients with hepatic impairment

LC Stansfield, WI Gonsalves, FK Buadi - Future Oncology, 2015 - Future Medicine
Novel drugs such as immunomodulators and proteasome inhibitors have improved the
survival of patients with multiple myeloma. Like all therapeutic agents, appropriate dosing …

A design for phase I trials in completely or partially ordered groups

MR Conaway - Statistics in medicine, 2017 - Wiley Online Library
We propose a design for dose finding for cytotoxic agents in completely or partially ordered
groups of patients. By completely ordered groups, we mean that prior to the study, there is …

A model‐assisted design for partially or completely ordered groups

C Celum, M Conaway - Pharmaceutical Statistics, 2024 - Wiley Online Library
This paper proposes a trial design for locating group‐specific doses when groups are
partially or completely ordered by dose sensitivity. Previous trial designs for partially ordered …

The quasi-CRM shift method for partially ordered groups

C Celum, BJ Horton, M Conaway - Contemporary Clinical Trials, 2024 - Elsevier
This paper proposes a phase-I clinical trial design that uses ordinal toxicity to locate group-
specific doses when groups are partially or completely ordered prior to the start of the trial …

Designs for phase I trials in ordered groups

MR Conaway, NA Wages - Statistics in medicine, 2017 - Wiley Online Library
We propose a new design for dose finding for cytotoxic agents in two ordered groups of
patients. By ordered groups, we mean that prior to the study there is clinical information that …