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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
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progressive disease
Secondary study objectives
Incidence of adverse events
Incidence of toxicities
Overall response rate
+2 more

Side effects data

From 2015 Phase 4 trial • 400 Patients • NCT01172639
33%
Upper respiratory tract infection
26%
Abdominal pain
23%
Nausea
19%
Gastroenteritis
16%
Hairloss
14%
Liver function disturbance
12%
Tendinopathy
12%
Arthralgia
9%
Eczema
9%
Vertigo
9%
Hypertension
7%
Arthrosis
7%
Increased transpiration
7%
Back pain
7%
Agitation
7%
Tooth extraction
7%
Paresthesia
7%
Pruritus
5%
Sjogren's disease
5%
Venous insufficiency
5%
Palpitations
5%
Anaemia
5%
Influenza infection
5%
Fatigue
5%
Muscle cramps
5%
Headache
5%
Bronchitis
5%
General malaise
5%
Arthritis
5%
Flushes
2%
Pyrosis
2%
Endometrioid adenocarcinoma
2%
Intervertebral disc disorder
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

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
602 Previous Clinical Trials
1,923,446 Total Patients Enrolled
38 Trials studying Multiple Myeloma
3,514 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,941 Previous Clinical Trials
41,023,399 Total Patients Enrolled
594 Trials studying Multiple Myeloma
191,432 Patients Enrolled for Multiple Myeloma
Michael A RosenzweigPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
109 Total Patients Enrolled
2 Trials studying Multiple Myeloma
85 Patients Enrolled for Multiple Myeloma

Media Library

Multiple Myeloma Research Study Groups: Treatment (leflunomide)
~0 spots leftby Dec 2024
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