Related Experiment Video

Updated: May 9, 2026

Tumor Treating Field Therapy in Combination with Bevacizumab for the Treatment of Recurrent Glioblastoma
06:15

Tumor Treating Field Therapy in Combination with Bevacizumab for the Treatment of Recurrent Glioblastoma

Published on: October 27, 2014

Results from the 5-year, phase IV RENEW (Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis)

Victor M Rivera, Douglas R Jeffery, Bianca Weinstock-Guttman

    BMC Neurology
    |July 12, 2013
    PubMed
    Abstract

    Insights

    The RENEW study monitored Mitoxantrone safety in 509 multiple sclerosis patients over 5 years. Results confirm Mitoxantrone

    Area of Science:

    • Neurology
    • Clinical Trials
    • Pharmacovigilance

    Background:

    • The Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis (RENEW) was a 5-year, phase IV study.
    • It monitored the safety of Mitoxantrone in a United States patient cohort.
    • The study focused on patients with secondary progressive multiple sclerosis (SPMS), progressive relapsing multiple sclerosis (PRMS), and worsening relapsing-remitting multiple sclerosis (RRMS).

    Purpose of the Study:

    • To evaluate the long-term safety profile of Mitoxantrone.
    • To assess Mitoxantrone's effects in specific multiple sclerosis (MS) subtypes.

    Main Methods:

    • 509 patients (395 SPMS, 81 worsening RRMS, 33 PRMS) were enrolled across 46 US MS treatment centers.
    • Patients received Mitoxantrone every 3 months as per package insert.
    • Laboratory workups and cardiac monitoring were conducted every 3 months during treatment and annually for 5 years.

    Main Results:

    • Of 509 patients, 172 (33.8%) completed the 5-year trial.
    • Cardiotoxicity (left ventricular ejection fraction reduction <50%) occurred in 5.3% during treatment and 5.6% during follow-up.
    • Congestive heart failure signs were observed in 2.0% of patients. Cumulative dose was the primary risk factor for cardiotoxicity.
    • Therapy-related leukemia occurred in 0.6% of patients. Persistent amenorrhea was reported in 22% of women with regular menses and 51% with irregular menses at baseline.

    Conclusions:

    • The RENEW study results align with the established safety profile of Mitoxantrone.
    • The study provides valuable long-term safety data for Mitoxantrone use in multiple sclerosis patients.

    Related Concept Videos

    Clinical Trials: Overview01:11

    Clinical Trials: Overview

    Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
    Treatment Resistent Cancers02:56

    Treatment Resistent Cancers

    Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
    Treatment Resistant Cancers02:56

    Treatment Resistant Cancers

    Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
    Drug Administration and Therapy Phases: Overview01:26

    Drug Administration and Therapy Phases: Overview

    Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
    The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
    The pharmacokinetic phase...
    Chemotherapy-Induced Nausea and Vomiting: Dopamine Receptor Antagonists01:29

    Chemotherapy-Induced Nausea and Vomiting: Dopamine Receptor Antagonists

    Dopamine receptor antagonists, also known as antipsychotic agents, are critical in managing chemotherapy-induced vomiting. These antiemetic agents block dopamine receptors in the chemoreceptor trigger zone (CTZ), inhibiting signal transmission to the vomiting center. Antipsychotic agents encompass phenothiazines (PTZ), butyrophenones, benzamides, and thienobenzodiazepines (Zyprexa), which are utilized for their antiemetic and sedative properties.
    Phenothiazines, such as prochlorperazine...
    Clinical Trials01:16

    Clinical Trials

    Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
    There are four phases in a clinical trial. A phase one...