← Back to Search

Proteasome Inhibitor

Lenalidomide + Dexamethasone +/- Bortezomib for Multiple Myeloma

Phase 3

Waitlist Available

Led By Brian M Durie

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must not have uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, myocardial infarction within the last 6 months, history of treatment for clinically significant ventricular cardiac arrhythmias, poorly controlled hypertension, or poorly controlled diabetes mellitus

Patients must have a Zubrod performance status (PS) of 0 - 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Study Summary

This trial looks at a new way to treat multiple myeloma by combining lenalidomide, dexamethasone, and bortezomib.

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who haven't had treatment before. They need to have enough healthy blood cells, no serious heart conditions, infections or other health issues that could interfere with the study. Women of childbearing age must test negative for pregnancy and agree to contraception.Check my eligibility

What is being tested?

The study compares two treatments: one group receives Lenalidomide and Dexamethasone; another gets these plus Bortezomib. It aims to find out which combination is more effective in stopping cancer growth by either killing cells or preventing them from dividing.See study design

What are the potential side effects?

Possible side effects include fatigue, risk of infection due to low blood cell counts, nerve damage (neuropathy), gastrointestinal symptoms like nausea or constipation, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I do not have severe heart issues, recent heart attack, uncontrolled infections, high blood pressure, or diabetes.

Select...

I can take care of myself, but I might not be able to do heavy physical work.

Select...

I can take aspirin daily or a substitute if I'm allergic.

Select...

I haven't had radiation to more than half of my pelvis.

Select...

I have never had a stroke that left me with lasting brain damage.

Select...

My kidney function is good, with a creatinine clearance over 30 cc/min.

Select...

I have not received chemotherapy for my current illness.

Select...

I have been recently diagnosed with multiple myeloma and it can be measured.

Select...

I have never been treated with bortezomib or lenalidomide.

Select...

My hemoglobin level is 9 g/dL or higher, even after treatments like transfusions or EPO.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Progression-free Survival

Secondary outcome measures

Overall Survival

Response Rates ()

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (dexamethasone, lenalidomide, bortezomib)Experimental Treatment4 Interventions

Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (dexamethasone and lenalidomide)Active Control3 Interventions

Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Bortezomib

2005

Completed Phase 2

~1140

Lenalidomide

2005

Completed Phase 3

~1480

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,628 Total Patients Enrolled

578 Trials studying Multiple Myeloma

188,205 Patients Enrolled for Multiple Myeloma

Brian M DuriePrincipal InvestigatorSWOG Cancer Research Network

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00644228 — Phase 3

Multiple Myeloma Research Study Groups: Arm I (dexamethasone and lenalidomide), Arm II (dexamethasone, lenalidomide, bortezomib)

Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT00644228 — Phase 3

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00644228 — Phase 3

Frequently Asked Questions

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

At how many different hospitals can patients participate in this trial?

"A few of the one hundred participating locations for this trial include the Pacific Cancer Institute of Maui in Wailuku, Hawaii, Penrose-Saint Francis Healthcare in Colorado Springs, Colorado, and Compass Oncology Rose Quarter in Portland, Oregon."

Answered by AI

What are the most popular disorders that Lenalidomide is used to target?

"Lenalidomide has been found to be an effective treatment for ophthalmia, sympathetic, at least two prior systemic chemotherapy regimens, and branch retinal vein occlusion."

Answered by AI

Would it be possible to join the clinical trial at this time?

"Recruitment for this clinical trial is not occurring presently. The trial was initially posted on April 1st, 2008 and was last updated on October 15th, 2022. If you are seeking other studies, there are 825 clinical trials actively admitting patients with multiple myeloma and 763 studies for Lenalidomide actively enrolling participants."

Answered by AI

Has the Food and Drug Administration given the okay to use lenalidomide?

"There is some clinical data supporting the efficacy of Lenalidomide, and it has been through multiple rounds of testing to confirm its safety. For these reasons, our team has rated Lenalidomide's safety as a 3."

Answered by AI

Which other treatments has Lenalidomide been compared to in previous research?

"Lenalidomide was first explored in a 2002 study conducted at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. In the nearly two decades since, there have been 2145 completed clinical trials. As of now, there are 763 trials that are actively recruiting participants, many of which are based in Wailuku, Hawaii."

Answered by AI

Recent research and studies

JAMA OncologyJournal

The Effect of Positive SWOG Treatment Trials on Survival of Patients with Cancer in the US Population

Unger, Joseph M., Michael LeBlanc, and Charles D. Blanke. 2017. “The Effect of Positive SWOG Treatment Trials on Survival of Patients with Cancer in the US Population”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2017.0762.

HaematologicaJournal

Extramedullary Disease Portends Poor Prognosis in Multiple Myeloma and Is Over-represented in High-risk Disease Even in the Era of Novel Agents

Usmani, S. Z., C. Heuck, A. Mitchell, J. Szymonifka, B. Nair, A. Hoering, Y. Alsayed, et al.. 2012. “Extramedullary Disease Portends Poor Prognosis in Multiple Myeloma and Is Over-represented in High-risk Disease Even in the Era of Novel Agents”. Haematologica. Ferrata Storti Foundation (Haematologica). doi:10.3324/haematol.2012.065698.

The LancetJournal

Bortezomib with Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone in Patients with Newly Diagnosed Myeloma Without Intent for Immediate Autologous Stem-cell Transplant (SWOG S0777): A Randomised, Open-label, Phase 3 Trial

Durie, Brian G M, Antje Hoering, Muneer H Abidi, S Vincent Rajkumar, Joshua Epstein, Stephen P Kahanic, Mohan Thakuri, et al.. 2017. “Bortezomib with Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone in Patients with Newly Diagnosed Myeloma Without Intent for Immediate Autologous Stem-cell Transplant (SWOG S0777): A Randomised, Open-label, Phase 3 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(16)31594-x.

The LancetJournal