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New treatment option for Relapse Multiple Myeloma
Official title Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07479979
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for relapse multiple myeloma.
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
- The primary objective of this Phase Ib/II trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS (on body delivery system) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold.
- 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
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the...
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of ≤2 within 28 days prior to registration. A performance status of \>2 will be allowed only if it is related to bone pain...
- Patients with a diagnosis of relapsed or relapsed/refractory MM who have received at least 1 line of prior therapy. In the phase 2 component, we will...
- del(17p), with a cutoff of \>20% clonal fraction, and/or TP53 mutation
You likely can't join if
- Active infection requiring systemic therapy (Note: people can be enrolled if they will be completing antibiotic therapy by the time of actual start...
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Known additional malignancy that is active and/or progressive, requiring urgent or new treatment. Exceptions include basal cell or squamous cell skin...
- Active central nervous system (CNS) metastases. NOTE: people who are symptomatic and have not undergone prior brain imaging must undergo a head...
- History of severe hypersensitivity reaction (grade 3 or more) to an anti-CD38 antibody that in the opinion of the investigator excludes the use of...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III...
See the full eligibility criteria
Who can join
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of ≤2 within 28 days prior to registration. A performance status of \>2 will be allowed only if it is related to bone pain that is expected to improve with treatment.
- Patients with a diagnosis of relapsed or relapsed/refractory MM who have received at least 1 line of prior therapy. In the phase 2 component, we will specifically enrich for patients with 1q gain or amplification as...
- del(17p), with a cutoff of \>20% clonal fraction, and/or TP53 mutation
- an IgH translocation including t(4;14), t(14;16), or t(14;20) along with 1q+ and/or del(1p32)
- monoallelic del(1p32) along with 1q+ or biallelic del(1p32)
- β2 microglobulin ≥5.5 mg/L with normal creatinine (\<1.2 mg/dL) For purposes of the study, patients with 2 or more of these high risk cytogenetic abnormalities. Patients known to carry such abnormalities on previous...
- Patients must have measurable disease as defined by at least one of the following:
- A monoclonal protein (M-protein): ≥ 0.5g/dL on serum protein electrophoresis or ≥ 200 mg of monoclonal protein on a 24-hour urine protein or involved serum light chain ≥ 10 mg/dl at time of relapse, or
- Biopsy proven plasmacytoma that can be assessed by physical exam or imaging, or
- If non- or oligo secretory, ≥10% plasma cells on BM biopsy/aspirate at time of relapse or plasmacytoma as described and/or evaluable disease by positron emission tomography, either MR or CT. Patients must be willing to...
- Due to the difficulty of quantitation using conventional SPEP of IgA and IgD monoclonal proteins, an absolute increase of \> 25 % over previous nadir of the total values in mg/dl (or adjusted units) will meet...
- Patients may have received any number and type of previous treatments for myeloma including carfilzomib and an anti-CD38 antibody but cannot be refractory to the combination of daratumumab and carfilzomib.
- Patients may not have received any anti-CD38 therapy within 6 months of start of study treatment (not enrollment).
- Previous allogeneic transplant is allowed provided the patient is not receiving ongoing systemic therapy for graft-versus-host disease (GVHD).
- Previous B-cell maturation antigen (BCMA)-directed therapy, including chimeric antigen receptor T-cell therapy (CAR-T) transplantation, antibody drug conjugates, or bispecific engagers is also allowed, provided there is...
- Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
- White blood cell (WBC): ≥ 1,500/mm3
- Absolute Neutrophil Count (ANC): ≥ 1,000/mm3 a (For people with known Duffy null phenotype (benign ethnic neutropenia), the lowest acceptable ANC will be 750/mm3)
- Platelet Count: ≥75,000/mm3
- Hemoglobin (Hgb): ≥ 8 g/dL
- Calculated creatinine clearance: ≥ 20 cc/min using the Cockcroft-Gault formula
- Total Bilirubin: ≤ 2 × upper limit of normal (ULN) (except patients with suspected Gilbert's syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of ≤ 3x ULN)
- Aspartate aminotransferase (AST): ≤ 3 × ULN
- Alanine aminotransferase (ALT): ≤ 3 × ULN
- Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 7 days prior to registration.
- Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or use an effective method(s) of contraception from the time of informed...
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
- Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) may be enrolled if the viral load by polymerase chain reaction (PCR) is...
- Patients with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection may be enrolled if the viral load by PCR is...
- Subject willing to provide mandatory bone marrow biopsy and peripheral blood laboratory testing for research purposes only.
What rules you out
- Active infection requiring systemic therapy (Note: people can be enrolled if they will be completing antibiotic therapy by the time of actual start date of treatment)
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Known additional malignancy that is active and/or progressive, requiring urgent or new treatment. Exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, prostate cancer on stable...
- Active central nervous system (CNS) metastases. NOTE: people who are symptomatic and have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to...
- History of severe hypersensitivity reaction (grade 3 or more) to an anti-CD38 antibody that in the opinion of the investigator excludes the use of these drugs.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III and IV), unstable angina pectoris, uncontrolled cardiac arrhythmia, or...
- Treatment with any investigational drug within 14 days prior to registration.
- Any previously active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment. This is likely to be a rare occurrence.
- Treatment with moderate or strong inhibitors/inducers of CYP3A within 7 days prior to Day 1 of Cycle 1. Potent inhibitors of CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir...
- Currently receiving a strong CYP3A4 inhibitor/inducer and unable to discontinue such medications.
- Prior exposure to a SINE compound, including selinexor.
- Exposure to anti-CD38 directed therapy (ex. daratumumab; isatuximab; daratumumab/hyaluronidase) within 6 months of study registration.
- Patients with an echocardiogram or other cardiac imaging study showing a LVEF of \<40% within 60 days of study registration.
- Presence of plasma cell leukemia at time of registration
- Patients with a history of POEMS syndrome or primary AL amyloidosis are excluded
The study team makes the final eligibility decision.
Where it's taking place
- Madison, Wisconsin, 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 Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.