Study Details

Open

Selinexor, Dara, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or RMM

The study is being done to find out if a drug called Selinexor will be effective when combined with Carfilzomib, Daratumumab, and Dexamethasone. This study is also being done to find out what effects, good and/or bad, these study treatments have on your cancer.

Age & Gender

18 years ~ 99 years
Male, Female

Location

United States (Nationwide)

What will be asked of you

During the screening period, patients will sign consent, have a physical exam, adverse event assessment, have vitals collected, have labs drawn, have an imaging scan, have a forced expiratory volume test, ECG, echo, and possibly a fresh biopsy. During treatment, patients will have physical exams, vitals collected, labs drawn, imaging scans, a bone marrow biopsy, patient questionnaires, study drug diary completion, and study drug treatment.

Incentives

The study drug selinexor will be provided at no charge while you are taking part in this study.

In-person visits:
20

Total length of participation:
Up to six months or more (depends on when you stop treatment due to either progression or alternative therapy)

Looking for Specific Volunteers

Able to participate:

Patient must have relapsed or relapsed/refractory Multiple Myeloma.
Patient must have measurable disease via imaging scan.
Patient must have received 1-3 lines of prior treatment.
Patient must have adequate bone marrow preserves, hepatic function, and renal function.
Patient must have adequate cardiac function assessed by echocardiogram.

Not eligible if:

Patient has been treated with Dartumumab within 24 weeks of study registration.
Patient is pregnant, nursing, or of childbearing potential (unless they are willing to employ adequate contraception).
Patient has a co-morbid systemic illness or other severe concurrent disease that makes the patient inappropriate for study treatment per the investigator.
Patient has any active CNS (central nervous system) involvement.
Patient received any treatment within 14 days prior to registration.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Samuel Rubinstein
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Multiple Myeloma)

IRB Number

23-1468

ClinicalTrials.gov

NCT04756401