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Recurrent Plasma Cell MyelomaPhase 2NCT04508790

Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

A Phase 2 study testing Dexamethasone, Leflunomide and Pomalidomide in people with Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, run by City of Hope Medical Center at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial studies how well leflunomide, pomalidomide, and dexamethasone work for the treatment of multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dexamethasone, Leflunomide and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
8 sitesUnited States
Study dates
24 Nov 2020to 14 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines
  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • If unavailable, exceptions may be granted with study principal investigator (PI) approval
  • Eastern Cooperative Oncology Group (ECOG) =< 2
  • Life expectancy > 3 months
Show all 28Show fewer
  • Diagnosis of multiple myeloma with measurable disease as defined by:
  • M-protein quantities >= 0.5 g/dL by serum protein electrophoresis (sPEP) or
  • >= 200 mg/24 hour urine collection by urine protein electrophoresis (uPEP) or
  • Serum free light chain (FLC) > 10.0 mg/dL involved light chain and an abnormal kappa/lambda ration in subjects without detectable serum or urine M-protein or
  • For subjects with immunoglobulin class A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level >= 0.50 g/dL
  • 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
  • Fully recovered from the acute toxic effects (except alopecia) to =< grade 2 to prior anti-cancer therapy
  • Absolute neutrophil count (ANC) >= 1.0 x 10^9/L (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  • NOTE: Screening ANC should be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
  • Platelets >= 75.0 x 10^9/L (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  • NOTE: Screening platelet count should be independent of platelet transfusions for at least 2 weeks
  • Hemoglobin >= 8.0 g/dL (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  • NOTE: Transfusion support is allowed
  • Total bilirubin =< 2 X upper limit of normal (ULN) (unless has Gilbert's disease) (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  • Aspartate aminotransferase (AST) =< 3.5 x ULN (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  • Alanine aminotransferase (ALT) =< 3.5 x ULN (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  • Alkaline phosphatase < 5 x ULN (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  • Creatinine clearance of >= 30 mL/min per 24 hour urine test (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 weeks after the last dose of protocol therapy
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Who cannot join

  • Prior treatment with leflunomide
  • Patients who are pomalidomide refractory, defined as subjects who progress on or within 60 days of pomalidomide when given as a single agent or in combinatorial therapies. Prior exposure to pomalidomide without refractoriness is allowed
  • Current or planned use of other anti-myeloma therapies besides leflunomide, pomalidomide, and dexamethasone
  • Current or planned growth factor or transfusion support until after initiation of treatment
  • Prior allogeneic transplant
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents
Show all 20Show fewer
  • Positive for tuberculosis or latent tuberculosis (TB)
  • Positive for hepatitis A, B, or C
  • Known human immunodeficiency virus (HIV) infection
  • Prior diagnosis of rheumatoid arthritis
  • Acute active infection requiring systemic therapy within 2 weeks prior to enrollment
  • Subject has history of anaphylaxis to thalidomide, lenalidomide, pomalidomide, cholestyramine or dexamethasone
  • Non-hematologic malignancies within the past 3 years, with the exceptions of
  • Adequately treated basal cell or squamous cell skin cancer,
  • Carcinoma in situ of the cervix,
  • Prostate cancer < Gleason grade 6 with stable prostate specific antigen (PSA), or
  • Successfully treated in situ carcinoma of the breast
  • Females only: Pregnant or breastfeeding
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

8 sites in 1 country

United States8 sites, 8 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Michael A. Rosenzweig, 626-256-4973 ext. 62405, mrosenzweig@coh.org

    Michael A. Rosenzweig

    Recruiting

  • City of Hope at Seacliff

    Huntington Beach, California, 92648

    Michael Rosenzweig, 626-218-4673, mrosenzweig@coh.org

    Recruiting

  • City of Hope at Antelope Valley

    Lancaster, California, 93534

    Michael Rosenzweig, 626-218-4673, mrosenzweig@coh.org

    Recruiting

  • City of Hope at Long Beach Elm

    Long Beach, California, 90813

    Michael Rosenzweig, 626-218-4673, mrosenzweig@coh.org

    Recruiting

  • City of Hope at Newport Beach Fashion Island

    Newport Beach, California, 92660

    Michael Rosenzweig, 626-218-4673, mrosenzweig@coh.org

    Recruiting

  • City of Hope at South Pasadena

    South Pasadena, California, 91030

    MIchael mic Rosenzweig, 6262184673, mrosenzweig@coh.org

    Recruiting

  • City of Hope at South Bay

    Torrance, California, 90503

    Michael Rosenzweig, 626-218-4673, mrosenzweig@coh.org

    Recruiting

  • City of Hope at Upland

    Upland, California, 91786

    MIchael Rosenzweig, 626-218-4673, mrosenzweig@coh.org

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Trial of Leflunomide, Pomalidomide, and Dexamethasone for Relapsed/Refractory Multiple Myeloma

This phase II trial studies how well leflunomide, pomalidomide, and dexamethasone work for the treatment of multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with pomalidomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving leflunomide with pomalidomide and dexamethasone may work better in treating multiple myeloma compared to pomalidomide and dexamethasone alone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To estimate the response rate and to evaluate the antitumor activity of the three-drug combination, leflunomide, pomalidomide, and dexamethasone, in patients with relapsed/refractory multiple myeloma.

SECONDARY OBJECTIVES:

  1. To characterize and evaluate toxicities, including type, frequency, severity, attribution, time course, and duration.

II. To obtain estimates of response duration, depth of response, clinical benefit, and survival (overall and progression-free).

OUTLINE:

Patients receive leflunomide orally (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.

After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.

Being tested
Dexamethasone, Leflunomide, Pomalidomide
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • LeflunomideDrug

    Also called Arava, SU101

    Given PO

  • PomalidomideDrug

    Also called 4-Aminothalidomide, Actimid, CC-4047, Imnovid

    Given PO

Study groups in NCT04508790
Study groupRoleWhat they receive
Treatment (leflunomide, pomalidomide, dexamethasone)ExperimentalPatients 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.
Receives: Drug: Dexamethasone; Drug: Leflunomide; Drug: Pomalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response

    Clopper Pearson binomial 95% confidence intervals will be calculated.

    Measured: Up to 1 year

Secondary outcomes (6)

  1. Incidence of adverse events

    Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)5. Observed toxicities will be summarized, for all dose levels, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.

    Measured: Up to 30 days after last dose

  2. Response duration

    Will be estimated using the product-limit method of Kaplan and Meier.

    Measured: Up to 1 year

  3. Depth of response

    Will be estimated using the product-limit method of Kaplan and Meier.

    Measured: Up to 1 year

  4. Clinical benefit response

    Clopper Pearson binomial 95% confidence intervals will be calculated.

    Measured: Up to 1 year

  5. Overall survival

    Will be estimated using the product-limit method of Kaplan and Meier.

    Measured: Up to 1 year

  6. Minimal residual disease (MRD) status

    A patient will be considered as having minimal residual diseases if a positive result is obtained using the Adaptive MRD testing. MRD testing will be performed at Adaptive Biotechnologies.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2020
  2. Study start24 Nov 2020
  3. Primary completion14 Feb 2027 (estimated)
  4. Study completion14 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04508790
Sponsor's protocol ID
19418
Other IDs
NCI-2020-01962, 19418
Status last verified
May 2026
First submitted
23 Apr 2020
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, Leflunomide and Pomalidomide in people with Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, run by City of Hope Medical Center at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04508790.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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