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A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.

ConditionMultiple Myeloma, Refractory
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaryopharm Therapeutics Inc

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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 >= 2 peripheral neuropathy with pain at baseline, regardless of whether or not the participant is currently receiving medication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Selinexor

    Drug

    Participants will receive Selinexor oral tablets.

  • Dexamethasone

    Drug

    Participants will receive Dexamethasone oral tablets.

  • Bortezomib

    Drug

    Participants will receive Bortezomib SC injection.

Treatment groups

127 Participants
are divided into 4 treatment groups
Group A: Selinexor + Low-dose Dexamethasone (Sd-40 BIW)Experimental treatment 2 interventions
Group B: Selinexor + Low-dose Dexamethasone (Sd-100 QW)Experimental treatment 2 interventions
Group C: Selinexor + Low-dose Dexamethasone (Sd-80 BIW)Experimental treatment 2 interventions
Group D: Selinexor + Bortezomib + Dexamethasone (SVd)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

Time frame
From the date of randomization up to death (approximately 60 months)

Secondary outcomes

1

Duration of Response (DOR)

Time frame
From the date of randomization to first disease progression or death (approximately 60 months)
2

Clinical Benefit Rate (CBR)

Time frame
From the date of randomization up to death (approximately 60 months)
3

Disease control rate (DCR)

Time frame
From the date of randomization up to death (approximately 60 months)
4

Progression-Free Survival (PFS)

Time frame
From the date of randomization to first disease progression or death (approximately 60 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karyopharm Therapeutics Inc

Lead sponsor

Source ClinicalTrials.gov
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