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Immunomodulatory Agent
Leflunomide for High-Risk Smoldering Multiple Myeloma
Phase < 1
Waitlist Available
Led By Michael A Rosenzweig
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
Study Summary
This trial is testing how well leflunomide works for treating patients with high-risk smoldering plasma cell myeloma, to delay disease progression.
Who is the study for?
This trial is for adults with high-risk smoldering multiple myeloma who haven't been treated with leflunomide before. Participants must not be pregnant, have a life expectancy over 3 months, and an ECOG performance status of 0-2 (which means they are fully active or at least capable of self-care). They should not have serious liver disease, HIV, recent acute infections, or other cancers within the last 3 years.Check my eligibility
What is being tested?
The study tests how well leflunomide works in delaying disease progression in patients with high-risk smoldering multiple myeloma. Leflunomide is an anti-inflammatory drug that may lower immune response to help treat cancer. The trial also assesses the quality-of-life impact on participants.See study design
What are the potential side effects?
Leflunomide can cause side effects like diarrhea, hair loss, rash, high blood pressure and liver problems. It might also weaken your immune system making you more prone to infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progressive disease
Secondary outcome measures
Incidence of adverse events
Incidence of toxicities
Overall response rate
+2 moreSide effects data
From 2015 Phase 4 trial • 400 Patients • NCT0117263933%
Upper respiratory tract infection
26%
Abdominal pain
23%
Nausea
19%
Gastroenteritis
16%
Hairloss
14%
Liver function disturbance
12%
Tendinopathy
12%
Arthralgia
9%
Vertigo
9%
Hypertension
9%
Eczema
7%
Increased transpiration
7%
Arthrosis
7%
Back pain
7%
Agitation
7%
Tooth extraction
7%
Paresthesia
7%
Pruritus
5%
Anaemia
5%
Venous insufficiency
5%
Palpitations
5%
Sjogren's disease
5%
Muscle cramps
5%
Influenza infection
5%
Fatigue
5%
Headache
5%
Bronchitis
5%
General malaise
5%
Arthritis
5%
Flushes
2%
Intervertebral disc disorder
2%
Pyrosis
2%
Endometrioid adenocarcinoma
2%
Rotator cuff lesion
2%
Bladder infection
2%
Eye infection
2%
Insomnia
2%
Diarrhoea
2%
Angina
2%
Kidney cancer malignant
2%
Pneumonia
2%
Cough
2%
Genital infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
CoBRA Slim Low Risk Group
Tight Step Up Low Risk Group
CoBRA Classic High Risk Group
CoBRA Slim High Risk Group
CoBRA Avant-garde High Risk Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (leflunomide)Experimental Treatment2 Interventions
Patients receive leflunomide PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leflunomide
FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,459 Total Patients Enrolled
6 Trials studying Plasma Cell Myeloma
666 Patients Enrolled for Plasma Cell Myeloma
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,488 Total Patients Enrolled
65 Trials studying Plasma Cell Myeloma
8,048 Patients Enrolled for Plasma Cell Myeloma
Michael A RosenzweigPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
73 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (leflunomide)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are they currently enrolling participants in this experiment?
"According to the clinicaltrials.gov platform, this trial has concluded its recruitment phase as of August 12th 2022, which is when it was last edited. Although no more participants are being accepted at this time, 823 other studies have ongoing opportunities for enrolment."
Answered by AI
Has there been any other research conducted around Leflunomide?
"Currently, 15 trials analyzing the effects of leflunomide are underway. Of these studies, two have progressed to phase 3 and require patient enrollment from 22 different sites located in Duarte, California."
Answered by AI
How many subjects are being monitored in this experiment?
"At this time, enrollment for the trial has been suspended. The protocol was first released on October 8th 2020 and had its last update on August 12th 2022. However, there are 808 other research studies exploring smoldering multiple myeloma as well as 15 trials recruiting patients to take part in leflunomide testing."
Answered by AI
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