A Phase 2b, Open-label, Multi-arm Clinical Trial of Selinexor Plus Low-dose Dexamethasone (Sd) in Patients With Penta-refractory Multiple Myeloma or Selinexor and Bortezomib Plus Low-dose Dexamethasone (SVd) in Patients With Triple-class Refractory Multiple Myeloma

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? Selinexor+Dexamethasone
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to assess the efficacy, antitumor activity, safety and tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with triple-class refractory multiple myeloma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age greater than or equal to (\>=)18 years at the time of signing informed consent.

• Written informed consent in accordance with federal, local, and institutional guidelines.

• 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 protein electrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA.

⁃ Urinary M-protein excretion \>= 200 mg/24 hours.

⁃ Free light chain (FLC) \>= 100 milligram per liter (mg/L), provided that the FLC ratio 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 have previously received at least 4 anti-MM prior therapies and have MM that is refractory to previous treatment with at least 2 proteasome inhibitors (PIs), at least 2 immunomodulatory agent (IMiDs), and 1 anti-cluster of differentiation (CD38) monoclonal antibody. Refractory is defined as lesser than or equal to (\<=) 25 percent (%) 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 and have been previously treated with \>=3 anti-MM therapies (with exposure to at least 2 PI drugs, at least 2 IMiDs, and 1 anti-CD38 monoclonal antibody), and be refractory to 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 days after completion of therapy.

• Only for arm SVd: Participants must have previously received 1 to 5 anti-MM prior therapies 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 of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 7 months for female and 4 months for male following the discontinuation of study treatment.

Locations
Other Locations
Greece
General Hospital of Athens Alexandra
RECRUITING
Athens
General Hospital of Athens Evaggelismos
RECRUITING
Athens
General Hospital of Athens ALEXANDRA
RECRUITING
Attiki
University General Hospital of Patras
COMPLETED
Pátrai
Theageneion Cancer Hospital
RECRUITING
Thessaloniki
Israel
Emek Medical Center
RECRUITING
Afula
Assuta Ashdod Medical Center
RECRUITING
Ashdod
Barzilai Medical Center
RECRUITING
Ashkelon
Soroka University Medical Center
ACTIVE_NOT_RECRUITING
Beersheba
Bnai-Zion Medical Center
RECRUITING
Haifa
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Meir Medical Center
COMPLETED
Kfar Saba
Rabin Medical Center (Beilinson Hospital)
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center at Tel HaShomer
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Karyopharm Medical Information
clinicaltrials@karyopharm.com
(888) 209-9326
Time Frame
Start Date: 2020-07-01
Estimated Completion Date: 2028-01
Participants
Target number of participants: 127
Treatments
Experimental: Selinexor + Low-dose Dexamethasone (Sd-40 BIW)
Participants will receive fixed dose of 40 milligram (mg) of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet twice weekly (BIW) on Days 1, 3, 8, 10, 15, 17, 22, and 24 of each 28-day cycle.
Experimental: Selinexor + Low-dose Dexamethasone (Sd-100 QW)
Participants will receive fixed dose of 100 mg of Selinexor oral tablet followed by 40 mg of low-dose Dexamethasone oral tablet once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. (Dexamethasone may be given as 20 mg on days 1 and 2 of each week at the discretion of the treating physician).
Experimental: Selinexor + Low-dose Dexamethasone (Sd-80 BIW)
Participants will receive fixed dose of 80 mg of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet BIW on Days 1, 3, 8, 10,15, 17, 22, and 24 of each 28-day cycle. Closed for recruitment.
Experimental: Selinexor + Bortezomib + Dexamethasone (SVd)
Participants will receive fixed dose of 100 mg of Selinexor oral tablet on Days 1, 8, 15, 22, and 29 followed by 1.3 milligram per square-meter (mg/m\^2) of Bortezomib subcutaneous (SC) injection on Days 1, 8, 15, and 22 and followed by 40 mg of low-dose Dexamethasone oral tablet on Days 1, 8, 15, 22, and 29 of each 35-day cycle (Dexamethasone dose may be split to 20 mg on days 1 and 2 of each week at the discretion of the treating physician). Closed for recruitment.
Authors
Dr. Miri Zekster
Related Therapeutic Areas
Sponsors
Leads: Karyopharm Therapeutics Inc

This content was sourced from clinicaltrials.gov

Similar Clinical Trials