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SIL as Maintenance Therapy in Multiple Myeloma

ConditionMultiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorNavy General Hospital, Beijing

About this trial

The goal of this phase 2 trial is to test the safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed Multiple Myeloma according World Health Organization (WHO) classification;

Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).

Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;

Patient is willing and able to adhere to the study visit schedule and other protocol requirements;

Disqualifiers

Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.

Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.

Pregnant or lactating women

Trial design

Design model

Single group

Treatments tested in this trial

  • Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy

    Drug

    Patients were treated by Selinexor (40mg po qw d1-28) combined with Ixazomib (4mg po on days 1, 8, and 15 in 28-day cycles) and Lenalidomide(10mg po qd d1-21) as Maintenance Therapy.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Maintenance TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

PFS was defined as the time from study entry until disease progression

Time frame
2 years

Secondary outcomes

1

EFS

EFS was defined as the time from treatment initiation to progression, relapse, new treatment, or death by any cause, whichever occurred first.

Time frame
2 years
2

OS

OS was defined as the time from treatment initiation to death by any cause.

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Navy General Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: