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Proteasome Inhibitor

Bortezomib/Carfilzomib + Lenalidomide + Dexamethasone for Multiple Myeloma

Phase 3

Waitlist Available

Led By Shaji Kumar

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Patients must be diagnosed with symptomatic standard-risk multiple myeloma (SR-MM) as defined by specific criteria

Patients must not have grade 2 or higher peripheral neuropathy, active, uncontrolled infection, or specific heart conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the baseline assessment at induction randomization to a decrease of 7 points, assessed up to 15 years

Awards & highlights

Study Summary

This trial is studying two different combinations of drugs to treat patients with newly diagnosed multiple myeloma.

Who is the study for?

This trial is for newly diagnosed multiple myeloma patients who've had certain prior chemotherapies but not treatments for symptomatic myeloma. They must agree to specific programs, meet contraceptive requirements, and have acceptable organ function and blood counts. HIV+ individuals can join if they meet extra criteria.Check my eligibility

What is being tested?

The study compares two drug combinations: Bortezomib with Lenalidomide and Dexamethasone versus Carfilzomib with the same drugs. It aims to find out which combination is more effective in stopping cancer cell growth by blocking enzymes or boosting the immune system.See study design

What are the potential side effects?

Potential side effects include nerve damage, low blood counts leading to increased infection risk or bleeding problems, liver issues reflected by abnormal tests, allergic reactions, fatigue, and possibly an increased risk of deep vein thrombosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of blood cancer called multiple myeloma and it's causing symptoms.

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I don't have severe nerve damage, uncontrolled infections, or serious heart problems.

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I do not have any uncontrolled health conditions or a history of specific disorders.

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I have had chemotherapy for myeloma but not certain other treatments.

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I meet the required health and activity level and don't have excluded medical conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the baseline assessment at induction randomization to a decrease of 7 points, assessed up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the baseline assessment at induction randomization to a decrease of 7 points, assessed up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the baseline assessment at induction randomization to a decrease of 7 points, assessed up to 15 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall survival (OS) for the maintenance analysis

Progression-free survival for the induction analysis

Secondary outcome measures

Change in the FACT-Ntx TOI for the early induction analysis

Change in the FACT-Ntx TOI for the end of induction analysis

Change in the FACT-Ntx TOI for the long-term maintenance analysis

+14 more

Other outcome measures

Change in gene expression levels

Change in mutation status

Circulating plasma cells and plasma cell proliferation

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D (lenalidomide)Experimental Treatment3 Interventions

Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (lenalidomide)Experimental Treatment3 Interventions

Patients receive lenalidomide PO daily on days 1-21. Treatment repeats every 4 weeks for 24 courses in the absences of disease progression or unacceptable toxicity.

Group III: Arm B (carfilzomib, lenalidomide, dexamethasone)Experimental Treatment5 Interventions

Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16; lenalidomide PO daily on days 1-21; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A (bortezomib, lenalidomide, dexamethasone)Experimental Treatment5 Interventions

Patients receive bortezomib SC or IV on days 1, 4, 8, and 11 of courses 1-8 and days 1 and 8 of courses 9-12; lenalidomide PO daily on days 1-14; and dexamethasone PO daily on days 1, 2, 4, 5, 8, 9, 11, and 12 of courses 1-8 and days 1, 2, 8, and 9 of courses 9-12. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 2

~1140

Carfilzomib

2017

Completed Phase 3

~1440

Dexamethasone

2007

Completed Phase 4

~2590

Lenalidomide

2005

Completed Phase 3

~1480

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

175,835 Total Patients Enrolled

3 Trials studying Multiple Myeloma

2,338 Patients Enrolled for Multiple Myeloma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,066 Total Patients Enrolled

578 Trials studying Multiple Myeloma

187,643 Patients Enrolled for Multiple Myeloma

Shaji KumarPrincipal InvestigatorECOG-ACRIN Cancer Research Group

15 Previous Clinical Trials

607 Total Patients Enrolled

15 Trials studying Multiple Myeloma

607 Patients Enrolled for Multiple Myeloma

Media Library

Multiple Myeloma Research Study Groups: Arm A (bortezomib, lenalidomide, dexamethasone), Arm B (carfilzomib, lenalidomide, dexamethasone), Arm C (lenalidomide), Arm D (lenalidomide)

Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT01863550 — Phase 3

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01863550 — Phase 3

Frequently Asked Questions

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

What are the main illnesses that Bortezomib targets?

"Bortezomib is most often associated with the treatment of ophthalmia, sympathetic. It can also play a role in treating branch retinal vein occlusion and macular edema when other forms of systemic chemotherapy have failed."

Answered by AI

Why did this clinical trial start in the first place?

"The primary goal of this clinical study, which will last up to 15 years, is to track the progression-free survival rate of patients. Additionally, researchers will also be measuring the incidence of grade 2 or worse peripheral neuropathy and cardiac toxicity during the induction phase."

Answered by AI

Are people still being enrolled in this research project?

"The clinicaltrials.gov website indicates that this study is no longer recruiting patients for participation. Although the trial's last update was on December 29th, 2021, it appears that 1612 other trials are still presently looking for individuals to enroll."

Answered by AI

Do many hospitals in North America offer this treatment to their patients?

"A few of the 100 other locations where this trial is taking place are Hope Cancer Clinic in Livonia, Michigan, Kaiser Permanente Washington in Seattle, Washington, and University of Miami Miller School of Medicine-Sylvester Cancer Center in Miami, Florida."

Answered by AI

How many people are currently signed up to participate in this research?

"As of December 29th, 2021, this study is no longer recruiting participants. The trial was initially posted on December 2nd, 2013 and ended after 8 years. There are currently 774 other clinical trials for Bortezomib enrolling patients with multiple myeloma."

Answered by AI

What are some other instances where Bortezomib has been studied?

"In 2002, the original study on bortezomib was conducted at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, there have been a total of 2250 completed trials worldwide. right now, 774 studies are ongoing; many in Livonia, Michigan."

Answered by AI

Could you explain the potential risks of taking Bortezomib?

"Bortezomib has received a score of 3 from our team at Power. This is due to the fact that it is a Phase 3 trial, and thus there is both evidence of efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Carfilzomib or Bortezomib in Combination with Lenalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Without Intention for Immediate Autologous Stem-cell Transplantation (ENDURANCE): A Multicentre, Open-label, Phase 3, Randomised, Controlled Trial

Kumar, Shaji K, Susanna J Jacobus, Adam D Cohen, Matthias Weiss, Natalie Callander, Avina K Singh, Terri L Parker, et al.. 2020. “Carfilzomib or Bortezomib in Combination with Lenalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Without Intention for Immediate Autologous Stem-cell Transplantation (ENDURANCE): A Multicentre, Open-label, Phase 3, Randomised, Controlled Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(20)30452-6.

clinicaltrials.govStudy

Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

2013. "Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01863550.

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