SIL as Maintenance Therapy in Multiple Myeloma

NCT06744894 | Not Yet Recruiting Phase 2

• 1 other identifier: SIL2024
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• PFS

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

  2 years

Secondary Outcomes (2)

• EFS

  2 years

• OS

  2 years

Study Arms (1)

Maintenance Therapy

EXPERIMENTAL

Patients were treated by Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy

Drug: Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy

Interventions

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.

Maintenance Therapy

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Documented response to ASCT (PR, VGPR, CR/stringent complete response \[sCR\]) according to IMWG criteria.

You may not qualify if:

• 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

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ixazomib; Lenalidomide; Maintenance

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Health Care Facilities Workforce and Services

Study Officials

• Liren Qian, PhD

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liren Qian, PhD

CONTACT

+861066947194; qlr2007@126.com

Liren Qian

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Associate Professor

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share