Leflunomide for Multiple Myeloma

City of Hope Medical Center, Duarte, CA
Multiple Myeloma+1 More ConditionsLeflunomide - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing the combination of leflunomide, pomalidomide, and dexamethasone to treat patients with multiple myeloma that has returned or is resistant to treatment.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Leflunomide
1
Leflunomide
1
Selinexor

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 1 year

Up to 1 year
Clinical benefit response
Depth of response
Minimal residual disease (MRD) status
Overall response
Overall survival
Response duration
Day 30
Incidence of adverse events

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Leflunomide
1
Leflunomide
1
Selinexor

Side Effects for

CoBRA Slim Low Risk Group
33%Upper respiratory tract infection
26%Abdominal pain
23%Nausea
19%Gastroenteritis
16%Hairloss
14%Liver function disturbance
12%Arthralgia
12%Tendinopathy
9%Vertigo
9%Hypertension
9%Eczema
7%Tooth extraction
7%Increased transpiration
7%Paresthesia
7%Back pain
7%Agitation
7%Arthrosis
7%Pruritus
5%Palpitations
5%Flushes
5%Venous insufficiency
5%Headache
5%General malaise
5%Bronchitis
5%Anaemia
5%Arthritis
5%Fatigue
5%Muscle cramps
5%Influenza infection
5%Sjogren's disease
2%Pneumonia
2%Intervertebral disc disorder
2%Cough
2%Genital infection
2%Angina
2%Eye infection
2%Endometrioid adenocarcinoma
2%Kidney cancer malignant
2%Insomnia
2%Bladder infection
2%Rotator cuff lesion
2%Diarrhoea
2%Pyrosis
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT01172639) in the CoBRA Slim Low Risk Group ARM group. Side effects include: Upper respiratory tract infection with 33%, Abdominal pain with 26%, Nausea with 23%, Gastroenteritis with 19%, Hairloss with 16%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.

Trial Design

1 Treatment Group

Treatment (leflunomide, pomalidomide, dexamethasone)
1 of 1

Experimental Treatment

29 Total Participants · 1 Treatment Group

Primary Treatment: Leflunomide · No Placebo Group · Phase 2

Treatment (leflunomide, pomalidomide, dexamethasone)Experimental Group · 3 Interventions: Dexamethasone, Leflunomide, Pomalidomide · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Leflunomide
FDA approved
Pomalidomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
535 Previous Clinical Trials
2,249,925 Total Patients Enrolled
35 Trials studying Multiple Myeloma
3,254 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,235,369 Total Patients Enrolled
565 Trials studying Multiple Myeloma
193,048 Patients Enrolled for Multiple Myeloma
Michael A RosenzweigPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
45 Total Patients Enrolled
2 Trials studying Multiple Myeloma
21 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your doctor expects you to live for at least 3 more months.
You have already received treatment for your condition with specific drugs, but your condition has either come back or has not improved. Your doctor does not recommend a transplant at this time, but it may be considered later.
The study allows patients to receive blood transfusions if needed.
References

Frequently Asked Questions

What conditions is leflunomide typically employed to address?

"Leflunomide can be prescribed to ease ophthalmic and sympathetic conditions, including branch retinal vein occlusion, macular edema, and assorted eye-related maladies." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies for participants in this experiment?

"Affirmative. Clinicaltrials.gov provides proof that this research is currently in the process of recruiting participants, with the initial posting having been made on November 27th 2020 and last updated on January 10th 2022. In total 29 people are needed to be enrolled at one medical site." - Anonymous Online Contributor

Unverified Answer

Have any other studies explored the efficacy of utilizing Leflunomide?

"To date, 583 medical trials are currently investigating the uses of leflunomide with 146 studies in its advanced phase 3. Most clinical research is conducted in Mishawaka, Indiana; nevertheless, there are 18799 locations across the globe conducting experiments involving this drug." - Anonymous Online Contributor

Unverified Answer

Does the Food and Drug Administration condone leflunomide?

"Taking into consideration that Leflunomide is in Phase 2 of its clinical trials, our team at Power have surmised a safety rating of 2 for the drug due to existing data on its security but no evidence yet supporting efficacy." - Anonymous Online Contributor

Unverified Answer

How many participants are engaged with this research endeavor?

"Confirmed. Clinicaltrials.gov displays that this medical trial, which was first announced on November 27th 2020, is still actively recruiting participants from one location with a target of 29 enrollees." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top