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Proteasome Inhibitor

Bortezomib for Multiple Myeloma

Phase 2

Waitlist Available

Led By Jacob Laubach

Research Sponsored by Dana-Farber Cancer Institute

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 survival was assessed up to 1 year.

Awards & highlights

Study Summary

This trial is testing a possible new treatment for multiple myeloma that combines three drugs.

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who haven't had systemic therapy yet. They must have certain levels of monoclonal protein, organ dysfunction related to myeloma, and be able to follow the study plan. Women must test negative for pregnancy and use birth control; men should also use contraception if with a female partner of childbearing potential.Check my eligibility

What is being tested?

The trial tests a drug combo: lenalidomide, subcutaneous bortezomib, and dexamethasone (RVD) as initial treatment for multiple myeloma. It includes those eligible after screening based on specific health criteria like kidney function and blood cell counts.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site from bortezomib, increased risk of infections due to lowered immunity from lenalidomide, and high blood sugar or mood changes from dexamethasone. Each patient's experience may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ survival was assessed up to 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~survival was assessed up to 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and survival was assessed up to 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

4-Cycle Induction Overall Response Rate (ORR)

Four-cycle Induction Peripheral Neuropathy (PN) Rate

Grade 3-4 Induction Peripheral Neuropathy Rate

+1 more

Secondary outcome measures

1-Year Progression Free Survival (PFS) Probability

1-year Overall Survival (OS) Rate

Median Duration of Response (DOR)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lenalidomide, subcutaneous Bortezomib, DexamethasoneExperimental Treatment5 Interventions

Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Autologous Stem Cell Transplant

2016

Completed Phase 2

~360

Bortezomib

2005

Completed Phase 2

~1140

Lenalidomide

2005

Completed Phase 3

~1480

Dexamethasone

2007

Completed Phase 4

~2590

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,826 Total Patients Enrolled

51 Trials studying Multiple Myeloma

34,276 Patients Enrolled for Multiple Myeloma

Millennium Pharmaceuticals, Inc.Industry Sponsor

404 Previous Clinical Trials

46,868 Total Patients Enrolled

82 Trials studying Multiple Myeloma

10,016 Patients Enrolled for Multiple Myeloma

CelgeneIndustry Sponsor

636 Previous Clinical Trials

128,925 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,817 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

How many venues can participants access this research experiment?

"A total of 8 medical centres are enrolling participants in this trial. Notable sites include Hematology Oncology of Northern New jersey, Eastern Maine Medical Center and Beth Israel Deaconess Medical Center, alongside 5 other locations."

Answered by AI

To what extent have there been prior experiments utilizing Bortezomib?

"Currently, there are 168 phase 3 trials actively exploring the potential of Bortezomib. Of these studies, 732 remain active while Joliet Illinois alone hosts several clinical trials on this medication. Moreover, 26078 medical centres around the world have conducted research concerning Bortezomib's efficacy."

Answered by AI

In which circumstances is Bortezomib typically prescribed?

"Bortezomib is mostly employed to treat ophthalmia, sympathetic. Additionally, it can be used for a variety of other illnesses, such as macular edema, branch retinal vein occlusion and two or more prior systemic chemotherapy regimens."

Answered by AI

Has the FDA accepted Bortezomib for clinical use?

"The level of safety associated with Bortezomib was estimated to be a 2 by our team at Power as it is currently in Phase 2 trials, suggesting that while there are some data points alluding to its safety, efficacy has yet to be proven."

Answered by AI

Is this research endeavor currently accepting participants?

"This study is no longer actively recruiting participants. It was initially posted in December of 2015 and edited most recently on February 11th 2022. For those seeking alternative studies, 807 trials involving multiple myeloma are presently enrolling and 732 clinical experiments utilizing bortezomib have vacancies for volunteers."

Answered by AI

What is the planned enrollment size for this research endeavor?

"At this moment, there are no open slots for participants in this trial. This medical study was first advertised on December 1st 2015 and most recently updated February 11th 2022. For those searching for other trials related to multiple myeloma or Bortezomib, 807 and 732 clinical trials are respectively recruiting patients across the globe."

Answered by AI

Recent research and studies

American Journal of HematologyJournal

Phase 2 Studies of Lenalidomide, Subcutaneous Bortezomib, and Dexamethasone as Induction Therapy in Patients with Newly Diagnosed Multiple Myeloma

O'Gorman, Peter, Jacob P. Laubach, Michael E. O'Dwyer, Janusz Krawczyk, Andrew J. Yee, Oonagh Gilligan, Mary R. Cahill, et al.. 2022. “Phase 2 Studies of Lenalidomide, Subcutaneous Bortezomib, and Dexamethasone as Induction Therapy in Patients with Newly Diagnosed Multiple Myeloma”. American Journal of Hematology. Wiley. doi:10.1002/ajh.26491.

clinicaltrials.govStudy

Phase II Study of Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib and Dexamethasone Therapy for Newly Diagnosed Multiple Myeloma

Jacob Laubach, MD 2015. "Phase II Study of Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib and Dexamethasone Therapy for Newly Diagnosed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02441686.

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