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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2023
  • participants needed
    29
  • sponsor
    City of Hope Medical Center
Updated on 25 March 2022
platelet count
cancer
serum pregnancy test
measurable disease
gilbert's syndrome
dexamethasone
colony stimulating factor
neutrophil count
tumor cells
g-csf
chemotherapy drugs
line of therapy
immunoglobulin
serum protein
electrophoresis
refractory multiple myeloma
pomalidomide

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. 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.

Description

PRIMARY OBJECTIVE:

I. 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:

I. 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.

Details
Condition Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Treatment Pomalidomide, Dexamethasone, leflunomide
Clinical Study IdentifierNCT04508790
SponsorCity of Hope Medical Center
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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
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)
not recommended. Participants may opt for a delayed transplant at a later
time, if appropriate
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
NOTE: Screening platelet count should be independent of platelet transfusions for at least 2 weeks
NOTE: Transfusion support is allowed
Platelets >= 75.0 x 10^9/L (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)
Hemoglobin >= 8.0 g/dL (performed within 30 days prior to day 1 of protocol therapy
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)
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
Total bilirubin =< 2 X upper limit of normal (ULN) (unless has Gilbert's disease)
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
(performed within 30 days prior to day 1 of protocol therapy unless otherwise
stated)
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
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

Exclusion Criteria

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
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)
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