Phase
Condition
Multiple Myeloma
Cancer
Leukemia
Treatment
Dexamethasone
Pomalidomide
Bortezomib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age greater than or equal to (>=)18 years at the time of signing informed consent.
Written informed consent in accordance with federal, local, and institutionalguidelines.
Measurable MM based on IMWG guidelines as defined by at least one of the following:
Serum M-protein >= 0.5 gram per deciliter (g/dL) by serum proteinelectrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitativeIgA.
Urinary M-protein excretion >= 200 mg/24 hours.
Free light chain (FLC) >= 100 milligram per liter (mg/L), provided that the FLCratio is abnormal.
Only for arms Sd-40 BIW, Sd-100 QW and Sd-80 BIW prior to protocol version (PV) 5.0:Participants must have relapsed or refractory multiple myeloma (RRMM) and havepreviously received at least 4 anti-MM prior therapies and have MM that isrefractory to previous treatment with at least 2 proteasome inhibitors (PIs), atleast 2 immunomodulatory agent (IMiDs), and 1 anti-cluster of differentiation (CD38)monoclonal antibody. Refractory is defined as lesser than or equal to (<=) 25percent (%) response to therapy, or progression during therapy or progression within 60 days after completion of therapy.
Only for Arms Sd-40 BIW and Sd-100 QW as of PV 5.0: Participants must have RR MM andhave been previously treated with >=3 anti-MM therapies (with exposure to at least 2PI drugs, at least 2 IMiDs, and 1 anti-CD38 monoclonal antibody), and be refractoryto at least 1 drug of each class (PI/IMiD/anti-CD38). Refractory is defined as <=25%response to therapy or progression during therapy or progression within 60 daysafter completion of therapy.
Only for arm SVd: Participants must have previously received 1 to 5 anti-MM priortherapies and have MM that is refractory to previous treatment with at least 1 PI,at least 1 IMiD, and 1 anti- CD38 monoclonal antibody.
Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
Female participants of childbearing potential must agree to use dual methods ofcontraception and have a negative serum pregnancy test at screening, and maleparticipants must use an effective barrier method of contraception if sexuallyactive with a female of childbearing potential. For both male and femaleparticipants, effective methods of contraception must be used throughout the studyand for 7 months for female and 4 months for male following the discontinuation ofstudy treatment.
Exclusion
Exclusion Criteria:
Active plasma cell leukemia.
Documented systemic amyloid light chain amyloidosis.
Active central nervous system MM.
Only for SVd arm: Greater than Grade 2 peripheral neuropathy or Grade >= 2peripheral neuropathy with pain at baseline, regardless of whether or not theparticipant is currently receiving medication.
Radiation, chemotherapy, immunotherapy, or any other anticancer therapy (includinginvestigational therapies) <= 2 weeks prior to Cycle 1 Day 1 (C1D1). (Steroids arepermitted up to 1 pulse of 40 mg per day for 4 days in the 2 weeks prior to C1D1).
Active graft vs. host disease (after allogeneic stem cell transplantation) at C1D1.
Ongoing clinically significant non-hematological toxicities from prior treatmentsthat are Grade greater than (>) 2 at C1D1.
Inadequate hepatic function defined as total bilirubin >= 2x upper limit of normal (ULN) (>= 3x ULN for participants with Gilbert's syndrome), aspartate transaminase (AST) >= 2.5x ULN, and alanine transaminase (ALT) >= 2.5x ULN.
Inadequate renal function defined as estimated creatinine clearance of lesser than (<) 20 milliliter per minute (mL/min), calculated using the formula of Cockroft andGault.
Inadequate hematopoietic function defined as the following:
Absolute neutrophil count (ANC) < 1000/cubic millimeter (mm^3)
Platelet count < 75,000/mm^3
Hemoglobin (Hb) level < 8.5 g/dL
Life expectancy of < 4 months, based on the opinion of the Investigator.
Major surgery within 4 weeks prior to C1D1.
Uncontrolled active infection requiring parenteral antibiotics, antivirals, orantifungals within 1 week prior to first dose.
Active gastrointestinal dysfunction interfering with the ability to swallow tablets,or any gastrointestinal dysfunction that could interfere with absorption of thestudy treatment.
Known active hepatitis A, B, or C infection; or known to be positive for hepatitis Cvirus RNA or hepatitis B virus surface antigen.
Female participants who are pregnant or lactating.
Known intolerance, hypersensitivity, or contraindication to glucocorticoid therapyat C1D1.
Concurrent therapy with approved or investigational anticancer therapeutic includingtopical therapies.
Prior exposure to a SINE compound, including selinexor.
Serious, active psychiatric or active medical conditions which, in the opinion ofthe Investigator or the Sponsor, could interfere with the participation in thestudy.
Contraindication to any of the required concomitant drugs or supportive treatments.
Study Design
Connect with a study center
University General Hospital of Patras
Patra, Achaia 2654
GreeceSite Not Available
University General Hospital of Patras
Pátrai 255683, Achaia 2654
GreeceCompleted
General Hospital of Athens "ALEXANDRA"
Attiki, Athens 11528
GreeceSite Not Available
General Hospital of Athens "Alexandra"
Attiki 264354, Athens 11528
GreeceActive - Recruiting
General Hospital of Athens "Alexandra"
Athens 264371, Attica 6692632 115 28
GreeceActive - Recruiting
General Hospital of Athens "Evaggelismos"
Athens 264371, Attica 6692632 10676
GreeceActive - Recruiting
General Hospital of Athens "Evangelismos"
Athens 264371, Attica 6692632 10676
GreeceActive - Recruiting
General Hospital of Athens "Evaggelismos"
Athens, Attiki 10676
GreeceSite Not Available
Theageneion Cancer Hospital
Thessaloniki 734077, Thessaloniki 54007
GreeceActive - Recruiting
Theageneion Cancer Hospital
Thessaloniki, 54007
GreeceSite Not Available
Emek Medical Center
Afula 295740, Afula 1834111
IsraelActive - Recruiting
Assuta Ashdod Medical Center
Ashdod 295629, Ashdod 7747629
IsraelActive - Recruiting
Bnai-Zion Medical Center
Haifa 294801, Haifa District 294800 3108
IsraelActive - Recruiting
Rambam Health Care Campus
Haifa 294801, Haifa District 294800 3109601
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem 281184, Jerusalem 293198 9112001
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem 281184, Jerusalem 293198 9103102
IsraelActive - Recruiting
Rabin Medical Center (Beilinson Hospital)
Petah Tikva 293918, Petah Tikva 49100
IsraelActive - Recruiting
The Chaim Sheba Medical Center at Tel HaShomer
Ramat Gan 293788, Ramat Gan 52621
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv 293397, Tel Aviv 293396 64239
IsraelActive - Recruiting
Emek Medical Center
Afula, 1834111
IsraelSite Not Available
Assuta Ashdod Medical Center
Ashdod, 7747629
IsraelSite Not Available
Barzilai Medical Center
Ashkelon, 7830604
IsraelSite Not Available
Barzilai Medical Center
Ashkelon 295620, 7830604
IsraelActive - Recruiting
Soroka University Medical Center
Beer-Sheva,
IsraelSite Not Available
Soroka University Medical Center
Beersheba 295530,
IsraelSite Not Available
Bnai-Zion Medical Center
Haifa, 3108
IsraelSite Not Available
Rambam Health Care Campus
Haifa, 3109601
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem, 9112001
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem, 9103102
IsraelActive - Recruiting
Meir Medical Center
Kfar Saba, 4428164
IsraelSite Not Available
Meir Medical Center
Kfar Saba 294514, 4428164
IsraelCompleted
Rabin Medical Center (Beilinson Hospital)
Petah Tikva, 49100
IsraelSite Not Available
The Chaim Sheba Medical Center at Tel HaShomer
Ramat Gan, 52621
IsraelSite Not Available
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelSite Not Available

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