Selinexor Plus VRd in High Risk Newly Diagnosed Multiple Myeloma

Sponsor
Xia Zhongjun
Study ID
NCT05422027
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs. Selinexor dose escalation: 40, 60mg respectively on day 1,8,15 for 21 days cycles
  • Bortezomib — DRUG
    The investigators gave patients subcutaneous bortezomib 1.3mg/sqm on days 1, 8,15 of a 21- day cycle. standard bortezomib-lenalidomide-dexamethasone
  • Lenalidomide — DRUG
    The investigators gave patients oral lenalidomide 25mg on days 1 to 14 of a 21-day cycle. standard bortezomib-lenalidomide-dexamethasone
  • Dexamethasone — DRUG
    The investigators gave patients oral dexamethasone 40mg on days 1, 8, 15 of a 21-day cycle. standard bortezomib-lenalidomide-dexamethasone

Study Details

This is a single-arm and open-label study to explore XVRd (ATG-010, Bortezomib, Lenalidomide and Dexamethasone) regimen in high-risk newly diagnosed multiple myeloma.The primary objective of the dose escalation study is to determine the safety, tolerability, and recommended phase II dose (RP2D) of selinexor; Then dose expansion at the RP2D level based on dose escalation phase will be conducted to evaluate the efficacy, safety and tolerability.The enrollment period for this study is expected to be approximately 12 months. The study will end when all patients have completed 12 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.

Key Dates

Start date
Jul 25, 2022
Status verified
Jun 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor-VRd（XVRd）
    bortezomib SC 1.3mg/sqm on day 1,4,8,11, lenalidomide oral 25 mg on day 1-14, and dexamethasone 40mg on day 1,8,15 in a 21-day cycle; Selinexor dose escalation: 40，60mg respectively on day 1,8,15 for 21-days cycles. Then Selinexor will be given at the recommended dose level on phase II.

Primary Outcome Measure

Dose Escalation: Maximum Tolerated Dose (MTD) [ Time Frame: Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days) ; ]

Central Contacts

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