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Proteasome Inhibitor

selinexor+bortezomib+dexamethasone (SVd) for Multiple Myeloma (BOSTON Trial)

Phase 3

Waitlist Available

Research Sponsored by Karyopharm Therapeutics Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 75 months

Awards & highlights

BOSTON Trial Summary

This trial will compare the efficacy of selinexor plus bortezomib and low-dose dexamethasone (SVd) to bortezomib and low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1-3 prior anti-MM regimens.

Eligible Conditions

Multiple Myeloma

BOSTON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 75 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 75 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 75 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS) as Assessed by IRC

Secondary outcome measures

Duration of Response (DOR) as Assessed by IRC

Number of Participants With Grade >= 2 Peripheral Neuropathy Events

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

+6 more

BOSTON Trial Design

2Treatment groups

Active Control

Group I: selinexor+bortezomib+dexamethasone (SVd)Active Control3 Interventions

Selinexor will be given on Days 1, 8, 15, 22, and 29 of each 35-day cycle. Bortezomib will be given Days 1, 8, 15, and 22 of each 35-day cycle. Dexamethasone will be given Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle.

Group II: bortezomib+dexamethasone (Vd)Active Control2 Interventions

Bortezomib will be given Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles. For cycles ≥ 9, bortezomib will be given on Days 1, 8, 15, and 22 of each 35-day cycle. Dexamethasone will be given on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles. For cycles ≥ 9, dexamethasone will be given on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle.

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Who is running the clinical trial?

Karyopharm Therapeutics IncLead Sponsor

87 Previous Clinical Trials

7,177 Total Patients Enrolled

22 Trials studying Multiple Myeloma

1,818 Patients Enrolled for Multiple Myeloma

Michael Kauffman, MD, PhDStudy DirectorKaryopharm Therapeutics Inc

9 Previous Clinical Trials

1,065 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any dangerous side effects associated with taking SVd?

"Selinexor+bortezomib+dexamethasone (SVd) has been given a safety score of 3 by our analysts. This is due to the fact that this is a Phase 3 trial, so there is some data to support efficacy as well as multiple rounds of data to support safety."

Answered by AI

What is the primary indication for the use of selinexor+bortezomib+dexamethasone (SVd)?

"selinexor+bortezomib+dexamethasone (SVd) is most often used to treat ophthalmia, sympathetic. Other disorders that SVd has shown to be effective against include branch retinal vein occlusion, macular edema, and communicable diseases."

Answered by AI

Could you provide a list of other times SVd has been tested in a clinical setting?

"The SVd treatment regimen was first studied in 2002 at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, there have been 1406 completed trials. There are presently 648 actively recruiting clinical trials, with a large number of these trials being performed out of Honolulu, Hawaii."

Answered by AI

Are there any spots left for participants in this trial?

"The study is not recruiting new participants at the moment. It was created on May 24th, 2017 and was last updated on November 23rd, 2021. There are 826 other trials for multiple myeloma and 648 for selinexor+bortezomib+dexamethasone (SVd) that are currently recruiting."

Answered by AI

How many study sites are being monitored for this trial?

"31 hospitals are participating in this study, with notable locations being Kaiser Permanente Hawaii in Honolulu, McFarland Clinic in Ames, and Emory University in Atlanta. A full list of locations can be found below."

Answered by AI

Recent research and studies

Journal of Hematology & OncologyJournal

Effect of Prior Treatments on Selinexor, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma

Mateos, Maria V., Maria Gavriatopoulou, Thierry Facon, Holger W. Auner, Xavier Leleu, Roman Hájek, Meletios A. Dimopoulos, et al.. 2021. “Effect of Prior Treatments on Selinexor, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma”. Journal of Hematology & Oncology. Springer Science and Business Media LLC. doi:10.1186/s13045-021-01071-9.

American Journal of HematologyJournal

Effect of Age and Frailty on the Efficacy and Tolerability of Once‐weekly Selinexor, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma

Auner, Holger W., Maria Gavriatopoulou, Sosana Delimpasi, Maryana Simonova, Ivan Spicka, Ludek Pour, Meletios A. Dimopoulos, et al.. 2021. “Effect of Age and Frailty on the Efficacy and Tolerability of Once‐weekly Selinexor, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma”. American Journal of Hematology. Wiley. doi:10.1002/ajh.26172.

The LancetJournal

Once-per-week Selinexor, Bortezomib, and Dexamethasone Versus Twice-per-week Bortezomib and Dexamethasone in Patients with Multiple Myeloma (BOSTON): A Randomised, Open-label, Phase 3 Trial

Grosicki, Sebastian, Maryana Simonova, Ivan Spicka, Ludek Pour, Iryrna Kriachok, Maria Gavriatopoulou, Halyna Pylypenko, et al.. 2020. “Once-per-week Selinexor, Bortezomib, and Dexamethasone Versus Twice-per-week Bortezomib and Dexamethasone in Patients with Multiple Myeloma (BOSTON): A Randomised, Open-label, Phase 3 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(20)32292-3.

American Journal of HematologyJournal