Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05422027

Selinexor Plus VRd in High Risk Newly Diagnosed Multiple Myeloma

Led by Xia Zhongjun · Updated on 2024-06-17

42

Participants Needed

4

Research Sites

179 weeks

Total Duration

On this page

Sponsors

X

Xia Zhongjun

Lead Sponsor

A

Antengene Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.

CONDITIONS

Official Title

Selinexor Plus VRd in High Risk Newly Diagnosed Multiple Myeloma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide written informed consent.
  • Age 18 years or older.
  • Newly diagnosed multiple myeloma with measurable disease meeting IMWG criteria.
  • Presence of at least one of the following: serum M-protein  5 g/L, 24-hour urinary M-protein  0.2 g, or serum free light chain  100 mg/L with abnormal ratio.
  • High-risk multiple myeloma as defined by mSMART 3.0 criteria, including specific genetic abnormalities, R-ISS Stage 3, high plasma cell S-phase, or high risk gene expression profile.
  • ECOG Performance Status of 0, 1, or 2; 3 allowed if due to myeloma.
  • No prior chemotherapy for multiple myeloma; no prior radiotherapy to large pelvis; limited prior steroid use.
  • Adequate liver function with specified bilirubin, AST, and ALT levels.
  • Adequate kidney function with creatinine clearance  30 mL/min.
  • Adequate blood counts within 7 days before treatment.
  • No hematopoietic growth factor treatment within 2 weeks before screening.
  • Appropriate time elapsed since last blood transfusions.
  • Ability to take prophylactic anticoagulant therapy.
  • Female patients of childbearing potential must use effective contraception and have a negative pregnancy test.
  • Male patients must use condoms if sexually active with females of childbearing potential.
Not Eligible

You will not qualify if you...

  • Plasma cell leukemia.
  • Active amyloidosis.
  • Central nervous system involvement by multiple myeloma.
  • Prior treatment with selective inhibitor of nuclear export (SINE) compounds.
  • Grade greater than 2 peripheral neuropathy or painful neuropathy.
  • Known intolerance or contraindications to study drugs.
  • Unstable or active cardiovascular conditions including symptomatic ischemia, significant arrhythmias, severe heart failure, or recent heart attack.
  • Known HIV infection.
  • Active hepatitis A, B, or C infection.
  • Pregnant or nursing women.
  • Life expectancy less than 6 months.
  • Active gastrointestinal problems affecting swallowing or drug absorption.
  • Serious psychiatric, medical, or other conditions that could interfere with treatment or consent.
  • Contraindications to required supportive treatments.
  • Concurrent diseases likely to interfere with study procedures.
  • Unwillingness or inability to comply with the study protocol.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China, 510000

Not Yet Recruiting

2

Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,

Guangzhou, Guangdong, China, 510060

Actively Recruiting

3

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510120

Not Yet Recruiting

4

Nanfang Hospital

Guangzhou, Guangdong, China, 510515

Not Yet Recruiting

Loading map...

Research Team

Z

Zhongjun Xia, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here