XVenD Group for Relapsed Or Refractory Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Miami, Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, FL
Relapsed Or Refractory Multiple Myeloma+2 More
Venetoclax - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this research is to determine whether the combination of selinexor, venetoclax, and dexamethasone therapy can increase anti-cancer effects in patients with translocation 11;14-positive (t(11;14)), relapsed/refractory myeloma (RRMM).

Eligible Conditions

  • Relapsed Or Refractory Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Relapsed Or Refractory Multiple Myeloma

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 3 years

Up to 10 months
Rate of Treatment-Emergent Adverse Events
Up to 3 years
Duration of Response (DoR)
Fraction of Participants Achieving Overall Response
Minimal Residual Disease Negative Complete Response Rate
Overall Survival (OS)
Progression-Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Relapsed Or Refractory Multiple Myeloma

Trial Design

1 Treatment Group

XVenD Group
1 of 1
Experimental Treatment

33 Total Participants · 1 Treatment Group

Primary Treatment: XVenD Group · No Placebo Group · Phase 2

XVenD GroupExperimental Group · 3 Interventions: Venetoclax, Selinexor, Dexamethasone · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1670
Selinexor
2020
Completed Phase 2
~1290
Dexamethasone
2007
Completed Phase 4
~2420

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Trial Background

Prof. Dickran Kazandjian, MD
Principal Investigator
University of Miami
Closest Location: University of Miami, Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, FL
N/AFirst Recorded Clinical Trial
1 TrialsResearching Relapsed Or Refractory Multiple Myeloma
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Plasma cells ≥ 30% in bone marrow.
Patients must have had a bone marrow (BM) biopsy proven plasma cell myeloma harboring the t(11;14) translocation as reported by a Clinical Laboratory Improvement Amendments (CLIA) certified assay (i.e.
You have a serum monoclonal protein concentration of 0.5 g/dl or more.
You have a urine monoclonal protein >200 mg/24 hour.
You have an abnormal serum free light chain ratio.
A measurable lesion on PET/CT or MRI ≥ 2 cm.
You have a PS of ≤ 3 (appendix A).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.