Leflunomide for Neoplasms, Plasma Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
City of Hope Medical Center, Duarte, CA
Neoplasms, Plasma Cell+3 More
Leflunomide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether leflunomide can delay the progression of multiple myeloma in African-American and European-American patients.

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Eligible Conditions

  • Neoplasms, Plasma Cell
  • Smoldering Plasma Cell Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Neoplasms, Plasma Cell

Study Objectives

This trial is evaluating whether Leflunomide will improve 2 primary outcomes and 3 secondary outcomes in patients with Neoplasms, Plasma Cell. Measurement will happen over the course of Up to 30 days after last dose.

At 2 years
Progression to multiple myeloma
Year 2
Progression-free survival
Year 2
Overall survival
Year 2
Freedom-from progression
Day 30
Incidence of adverse events

Trial Safety

Safety Progress

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

Other trials for Neoplasms, Plasma Cell

Trial Design

1 Treatment Group

Treatment (leflunomide)
1 of 1
Experimental Treatment

This trial requires 20 total participants across 1 different treatment group

This trial involves a single treatment. Leflunomide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (leflunomide)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
Leflunomide
FDA approved
Cholestyramine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 2 years for reporting.

Closest Location

City of Hope Medical Center - Duarte, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All subjects must have the ability to understand and the willingness to sign a written informed consent
Patients must be age >= 18 years
Patients must have a life expectancy of > 24 months
Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patients must identify as African-American OR European-American
Bone marrow plasma cell percentage (BMPC%) > 20%
Serum M-protein > 2 g/dL
Free light chain ratio (FLCr) > 20
A diagnosis of high-risk SMM must have been made within the last 3 years
At least 2 weeks from prior therapy to time of start of treatment. Prior therapy includes steroids (except prednisone or equivalent - up to 10 mg per day is allowed)

Patient Q&A Section

Who should consider clinical trials for smoldering multiple myeloma?

"Patients with smoldering MM derive similar benefit from clinical trials when compared to non-smoldering patients. Interestingly however, smoldering patients with high ISS (>or=3) do not seem to benefit from clinical trials. This would imply that moderate ISS (<or=3) patients may also benefit from clinical trials. It remains to be seen whether these differences will translate into improved OS and PFS." - Anonymous Online Contributor

Unverified Answer

What is leflunomide?

"Leflunomide is effective in controlling both active and smoldering MM that is refractory to bortezomib alone. It has an acceptable tolerability profile. For some patients who have high-risk smoldering MM, it offers a potential long-term benefit." - Anonymous Online Contributor

Unverified Answer

Does smoldering multiple myeloma run in families?

"Results from a recent clinical trial of this study suggest that SMM does not run in families. It seems likely that the predisposition to SMM in a family member here is of genetic origin, and is unlikely to be due to environmental factors." - Anonymous Online Contributor

Unverified Answer

Can smoldering multiple myeloma be cured?

"This report indicates that MM patients who have developed hypercalcemia during therapy will be unlikely to benefit from additional therapy but should be monitored carefully." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating smoldering multiple myeloma?

"Although there have been advances in the treatment of smoldering multiple myeloma, the role of conventional chemotherapy remains a major part of this disease management. In spite of its difficulties, the management of smoldering multiple myeloma must continue to be managed appropriately." - Anonymous Online Contributor

Unverified Answer

How does leflunomide work?

"Leflunomide appears effective in controlling disease activity in smoldering MM in this pilot study. The agents' mode of action remains to be elucidated. Further studies with larger numbers of patients are needed before conclusions about its use in MM can be made." - Anonymous Online Contributor

Unverified Answer

Has leflunomide proven to be more effective than a placebo?

"A low dose of leflunomide is well tolerated and effective with a rapid clinical response, which suggests this drug could be used alone or as an alternative to other drugs in the induction phase of myeloma. Further safety testing is warranted." - Anonymous Online Contributor

Unverified Answer

Is leflunomide safe for people?

"Leflunomide is generally well tolerated in people with smoldering MM. It was associated with a lower risk of death from any cause compared with other maintenance therapies." - Anonymous Online Contributor

Unverified Answer

How many people get smoldering multiple myeloma a year in the United States?

"As of 2015, about 7,000 new cases of SMM were diagnosed each year in the US. Although the incidence of SMM has remained stable since 2000, the number of people diagnosed with SMM continues to increase." - Anonymous Online Contributor

Unverified Answer

What is smoldering multiple myeloma?

"Smoldering MM accounts for 10% of all MM cases and may affect up to 80% of all newly diagnosed MM patients. It is characterized by minimal clinical, biochemical, and radiological (e.g., bone marrow plasma cell percentage <5%) disease activity. Patients who satisfy the mandatory criteria for diagnosis of MM should undergo staging investigations in order to identify patients at risk of developing active MM." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing smoldering multiple myeloma?

"Women who had one or two pregnancies were three times more likely than those who had none to develop SMM. Although most women who developed SMM had no symptoms or only mild symptoms, about half had disease which was progressing slowly. A fivefold increase in risk of developing SMM in women who had been pregnant was found when compared with non-pregnant women. Because of this increased risk, women should be educated about their risks of developing SMM, and informed consent must be obtained prior to any procedure that could result in pregnancy." - 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.
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