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Immunomodulatory Agent
Leflunomide for High-Risk Smoldering Multiple Myeloma
Phase 2
Recruiting
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
Calculated creatinine clearance (CrCl) >= 30 mL/min per 24-hour urine collection or the Cockcroft-Gault formula
Adequate pulmonary function as defined by forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted by pulmonary function testing
Must not have
Adequately treated basal cell or squamous cell skin cancer
Carcinoma in situ of the cervix
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after last dose
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at the effects of leflunomide in treating patients with high-risk smoldering multiple myeloma who are African-American or European-American. Leflunomide is used to decrease the body's immune response and may delay the symptoms of multiple myeloma.
Who is the study for?
This trial is for African-American and European-American adults with high-risk smoldering multiple myeloma. Participants must have a life expectancy over 24 months, no hepatitis or HIV, not be pregnant or breastfeeding, agree to use contraception, and have specific blood counts and organ function levels. They should not have had previous treatments for this condition or certain other cancers within the last 3 years.
What is being tested?
The trial is testing leflunomide's effectiveness in delaying symptoms of high-risk smoldering multiple myeloma in African-American and European-American patients. It involves taking leflunomide to reduce immune response as a potential treatment strategy.
What are the potential side effects?
Leflunomide may cause side effects such as diarrhea, hair loss, rash, high blood pressure, liver problems (like elevated liver enzymes), nausea, numbness or tingling in hands or feet (neuropathy), respiratory infections like pneumonia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine clearance, is adequate.
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My lung function tests show at least half the normal capacity.
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I am able to get out of my bed or chair and move around.
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I am 18 years old or older.
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I have been diagnosed with high-risk smoldering multiple myeloma.
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I am a woman who can still have children.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated for skin cancer.
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I have early-stage cervical cancer.
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I have been diagnosed with rheumatoid arthritis.
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I have had a transplant from a donor.
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I am HIV positive.
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I have one or more bone lesions detectable by scans.
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I have been successfully treated for a non-invasive breast cancer.
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My prostate cancer is low grade with a stable PSA level.
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I have been treated with leflunomide before.
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My condition has caused damage to my organs.
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I have received treatment for early-stage multiple myeloma.
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My kidney function is low, with creatinine clearance below 30 mL/min or serum creatinine above 2 mg/dL.
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I have a liver condition.
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I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after last dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Side 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%
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%
Endometrioid adenocarcinoma
2%
Pyrosis
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
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 on days 1-28. 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
Cholestyramine
2018
Completed Phase 4
~340
Leflunomide
2003
Completed Phase 4
~1670
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
605 Previous Clinical Trials
1,923,549 Total Patients Enrolled
38 Trials studying Multiple Myeloma
3,459 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,333 Total Patients Enrolled
594 Trials studying Multiple Myeloma
191,361 Patients Enrolled for Multiple Myeloma
Michael A RosenzweigPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
3 Previous Clinical Trials
54 Total Patients Enrolled
2 Trials studying Multiple Myeloma
30 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have at least one small abnormal area (5 millimeters or larger) on your MRI scan.You do not have hepatitis A, B, or C infection.You have had allergic reactions to drugs similar to leflunomide and cholestyramine.My kidney function, measured by creatinine clearance, is adequate.I haven't had cancer other than lung cancer in the past 3 years.Your involved serum free light chain ratio is 100 or higher.My lung function tests show at least half the normal capacity.You are expected to live for more than 24 months.If you have at least two of the listed risk factors.I have been treated for skin cancer.I have early-stage cervical cancer.You have more than 20% of a certain type of cells in your bone marrow.I have been diagnosed with rheumatoid arthritis.I have had a transplant from a donor.I am HIV positive.I have one or more bone lesions detectable by scans.I am able to get out of my bed or chair and move around.I was diagnosed with high-risk smoldering multiple myeloma within the last 3 years.I am 18 years old or older.You do not have tuberculosis, as shown by a specific test called the T-Spot test.I have been successfully treated for a non-invasive breast cancer.My cancer has at least one known biomarker.Your blood calcium levels are too high, which is a sign of a health problem.My prostate cancer is low grade with a stable PSA level.Your hemoglobin level is either too low or too high.I have been treated with leflunomide before.My CRAB symptoms are not caused by my current illness.I am not using, nor plan to use, other experimental treatments or certain therapies during the study.Women who can have children must have a negative pregnancy test.Your AST and ALT levels should be less than 2 times the upper limit of normal.I haven't had any cancer treatment or steroids (except low-dose prednisone) in the last 2 weeks.My condition has caused damage to my organs.I have been diagnosed with high-risk smoldering multiple myeloma.I am a woman who can still have children.You have a high level of M-protein in your blood.Your body has enough infection-fighting white blood cells.I have received treatment for early-stage multiple myeloma.Your bilirubin levels in the blood are within normal range.Your bone marrow contains over 60% of a certain type of cells called plasma cells.My kidney function is low, with creatinine clearance below 30 mL/min or serum creatinine above 2 mg/dL.I have a liver condition.I am not pregnant or breastfeeding.The ratio of certain proteins in your blood is higher than normal.I have not had a serious infection needing treatment in the last 2 weeks.My platelet count is at least 50,000 and I haven't had a transfusion in 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (leflunomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.