← Back to Search

Corticosteroid

Triple Drug Therapy for 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
Diagnosis of multiple myeloma with measurable disease as defined by:
Relapsed or refractory to at least 1 prior line of therapy, including both a proteasome inhibitor and an immunomodulatory drug, and for whom transplant is not recommended. Participants may opt for a delayed transplant at a later time, if appropriate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

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.

Who is the study for?
This trial is for adults with multiple myeloma that has returned or isn't responding to treatment. They must have had at least one prior therapy, be in relatively good health (ECOG <=2), and not planning a transplant soon. Participants need measurable levels of cancer markers in their blood/urine and adequate organ function. Women of childbearing age must test negative for pregnancy and agree to birth control.Check my eligibility
What is being tested?
The study tests the combination of leflunomide, pomalidomide, and dexamethasone against multiple myeloma. Leflunomide may block enzymes needed by cancer cells; pomalidomide could alter the immune system's response to tumor cells; dexamethasone aims to stop cancer cell growth.See study design
What are the potential side effects?
Potential side effects include weakened immunity leading to infections, liver issues reflected by altered blood tests, possible allergic reactions similar to those from related drugs, fatigue due to anemia or low blood counts, and gastrointestinal problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with multiple myeloma and it can be measured.
Select...
My condition did not improve after treatment with a proteasome inhibitor and an immunomodulatory drug, and transplant is not currently recommended for me.
Select...
I am capable of having children and have not been surgically sterilized.
Select...
I am a woman who can have children and my pregnancy test is negative.
Select...
I am able to get out of my bed or chair and move around.
Select...
My IgA myeloma is measured by IgA levels, which are 0.50 g/dL or higher.
Select...
I have recovered from side effects of cancer treatment, except for hair loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response
Secondary outcome measures
Clinical benefit response
Depth of response
Incidence of adverse events
+3 more

Side effects data

From 2015 Phase 4 trial • 400 Patients • NCT01172639
38%
Upper respiratory tract infection
23%
Nausea
19%
Back pain
19%
Abdominal pain
13%
Hairloss
13%
Liver function disturbance
11%
Eczema
11%
Fatigue
11%
Aphtosis
9%
Influenza infection
9%
Renal insufficiency
9%
Muscle cramps
9%
Diarrhoea
9%
Dyspnea
6%
Pyrosis
6%
Urinary tract infection
6%
Headache
6%
Gastroenteritis
6%
Syncope
6%
Vertigo
6%
Arthralgia
6%
Bronchitis
4%
Tendinopathy
4%
Anaemia
4%
Arthrosis
4%
Palpitations
4%
Pruritus
2%
Sjogren's disease
2%
Ischialgy leg
2%
Hypertension
2%
Increased transpiration
2%
General malaise
2%
Arthritis
2%
Trauma
2%
Anaphylaxis after a wasp sting
2%
Coronary artery disorder
2%
Rotator cuff lesion
2%
Venous insufficiency
2%
Angina
2%
Atrioventricular block third degree
2%
Transient ischemic attack
2%
Orthopaedic surgery
2%
Abdominal surgery
2%
Peripheral vascular ischemia
2%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tight Step Up Low Risk Group
CoBRA Slim 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, pomalidomide, dexamethasone)Experimental Treatment3 Interventions
Patients receive leflunomide PO on days 1-28, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. 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
Dexamethasone
2007
Completed Phase 4
~2590
Leflunomide
2003
Completed Phase 4
~1670
Pomalidomide
2011
Completed Phase 2
~1020

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,223 Total Patients Enrolled
37 Trials studying Multiple Myeloma
3,430 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,318 Total Patients Enrolled
573 Trials studying Multiple Myeloma
188,004 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

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04508790 — Phase 2
Multiple Myeloma Research Study Groups: Treatment (leflunomide, pomalidomide, dexamethasone)
Multiple Myeloma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT04508790 — Phase 2
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04508790 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~2 spots leftby Jun 2024