Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in TIE Newly Diagnosed MM Patients (SABLe)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2029
  • participants needed
    100
  • sponsor
    Ida Bruun Kristensen
Updated on 10 May 2022
platelet count
antibiotics
measurable disease
bone marrow procedure
erythropoietin
dexamethasone
lenalidomide
neutrophil count
chemotherapy regimen
bortezomib

Summary

An open-label randomized (1:1) phase 2 study between a standard arm of VRD light versus an experimental arm of selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed, transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up within the Nordic Multiple Myeloma Study Group

Description

An open-label randomized (1:1) phase 2 study between a standard arm of VRD light versus an experimental arm of selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up with in the Nordic Multiple Myeloma Study Group.

Each arm will include 50 patients with a total number of participants of 100 patients, recruited within the NMSG collaborating countries. After induction patient will be treated with continued lenalidomide-dexamethasone according to SWOG, with continuous 40mg selinexor weekly in the selinexor arm (experimental arm B).

Details
Condition Multiple Myeloma
Treatment bortezomib injection, Dexamethasone Oral, Lenalidomide capsule, Selinexor 20 MG Oral Tablet
Clinical Study IdentifierNCT04717700
SponsorIda Bruun Kristensen
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible to enroll in this
study
Age > 18 years
Willing and able to provide written informed consent in accordance with national
local, and institutional guidelines. The patient must provide informed consent prior
to the first screening procedure
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 2. ECOG 3
allowed if caused by myeloma
Newly diagnosed multiple myeloma with treatment demanding disease as defined by IMWG
Adequate hepatic function within 7 days prior to C1D1
(Rajkumar, Dimopoulos et al. 2014) and measurable disease as defined IMWG 2016
criteria (Table 5) (Kumar, Paiva et al. 2016)
By treating physician considered in-eligible for high-dose therapy with stem-cell
transplant
Patients must have received no prior chemotherapy for multiple myeloma. Patients must
Erythropoietin-analogues are allowed
have received no prior radiotherapy to a large area of the pelvis (more than half of
Patients must have
the pelvis). Patients must have received no prior steroid treatment for myeloma with
the exception of a maximum of 14 days of treatment for symptom control (including
dexamethasone 40mg)
Total bilirubin < 1.5 × upper limit of normal (ULN) (except patients with
Gilbert's syndrome who must have a total bilirubin of < 3 × ULN), and
Alanine aminotransferase (ALT) normal to <2 × ULN
Adequate renal function within 7 days prior to C1D1 as determined by estimated GFR of
≥ 30 mL/min, calculated using standard formula
Adequate hematopoietic function within 7 days prior to C1D1: Absolute neutrophil
count ≥1000/mm3, and platelet count ≥100,000/mm3 (patients for whom <50% of bone
marrow nucleated cells are plasma cells). If cytopenias are due a plasma cell
infiltration in the bone marrow (biopsy-proven heavy-marrow involvement, as
defined by having at least 30% marrow cellularity, with > 50% of the cells being
malignant plasma cells (documented marrow results required)); in this case
although there are no required lower limits of normal for the blood counts, the
treating physician must use his/her medical judgment as to the appropriateness of
this study therapy for these patients
At least a 1-week interval from the last platelet transfusion prior to the
screening platelet assessment
However, patients may receive RBC and/or platelet transfusions as clinically indicated
per institutional guidelines during the study
Female patients of childbearing potential must have a negative serum pregnancy test at
Screening. Female patients of childbearing potential and fertile male patients who are
sexually active with a female of childbearing potential must use highly effective
methods of contraception throughout the study and for 3 months following the last dose
of study treatment
Patients must be able to take prophylactic anticoagulation as recommended by study
Patients with pathologic fractures, infection at diagnosis or symptomatic
hyperviscosity must have these conditions attended to prior to registration (i.e
intramedullary rod, I.V. antibiotics, plasmapheresis)

Exclusion Criteria

Exclusion Criteria
study
Has received selinexor or another XPO1 inhibitor previously
Pregnant or breastfeeding females
Life expectancy of less than 6 months
Active, unstable cardiovascular function, as indicated by the presence of
Symptomatic ischemia, or
Myocardial infarction within 6 months prior to C1D1
Contraindication to any of the required concomitant drugs or supportive treatments
Patients unwilling or unable to comply with the protocol
Patients meeting any of the following exclusion criteria are not eligible to enroll in this
Has any concurrent medical condition or disease (eg, uncontrolled active hypertension
uncontrolled active diabetes, active systemic infection, etc.) that is likely to
interfere with study procedures
Known intolerance, hypersensitivity, or contraindication to glucocorticoids
bortezomib, lenalidomide and selinexor
Uncontrolled clinically significant conduction abnormalities (eg, patients with
ventricular tachycardia on anti-arrhythmics are excluded; patients with first
degree atrioventricular block or asymptomatic left anterior fascicular
block/right bundle branch block will not be excluded), or
Congestive heart failure of New York Heart Association Class ≥3 or known left
ventricular ejection fraction <40%, or
Any active gastrointestinal dysfunction interfering with the patient's ability to
swallow tablets, or any active gastrointestinal dysfunction that could interfere with
absorption of study treatment
Inability or unwillingness to take supportive medications such as anti-nausea and
anti-anorexia agents as recommended by the National Comprehensive Cancer Network®
(NCCN) Clinical Practice Guidelines in Oncology (CPGO) (NCCN CPGO) for antiemesis and
anorexia/cachexia (palliative care)
Any active, serious psychiatric, medical, or other conditions/situations that, in the
opinion of the Investigator, could interfere with treatment, compliance, or the
ability to give informed consent
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