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New treatment option for Recurrent Plasma Cell Myeloma
Official title Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT04508790
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for recurrent plasma cell myeloma.
Also referred to as Aacidexam, Adexone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Prior treatment with leflunomide
- Patients who are pomalidomide refractory, defined as people who progress on or within 60 days of pomalidomide when given as a single agent or in...
- 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
See the full eligibility 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 people without detectable serum or urine M-protein or
- For people 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...
- 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...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- Prior treatment with leflunomide
- Patients who are pomalidomide refractory, defined as people who progress on or within 60 days of pomalidomide when given as a single agent or in combinatorial therapies. Prior exposure to pomalidomide without...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Huntington Beach, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Newport Beach, California, United States
- South Pasadena, California, United States
- Torrance, California, United States
- Upland, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Huntington Beach, California, United States; Lancaster, California, United States; Long Beach, California, United States; Newport Beach, California, United States; South Pasadena, California, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.