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Proteasome Inhibitor

Bortezomib/Dexamethasone + Lenalidomide for Multiple Myeloma

Phase 2

Waitlist Available

Led By Hani Hassoun, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have symptomatic multiple myeloma without advanced organ damage

Age 18 or greater at the time of signing the informed consent document

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new approach to treatment that may be just as effective with fewer side effects.

Who is the study for?

This trial is for adults with symptomatic multiple myeloma who haven't had prior systemic therapy, except under certain conditions. They must not be planning a stem cell transplant as initial treatment and should have an ECOG performance status ≤ 2, indicating they can perform daily activities with some limitations. Participants need functioning kidneys, no severe heart issues or recent heart attacks, and cannot be pregnant or breastfeeding.Check my eligibility

What is being tested?

The study tests if starting treatment with Bortezomib/Dexamethasone and adding Lenalidomide later only for non-responders can effectively manage Multiple Myeloma with fewer side effects. It's a sequential approach where all patients begin with two drugs instead of the standard three-drug combination to see if similar benefits can be achieved more safely.See study design

What are the potential side effects?

Potential side effects include nerve damage (neuropathy), low blood counts leading to increased infection risk or bleeding problems, fatigue, digestive issues like nausea or constipation from Bortezomib/Dexamethasone. Adding Lenalidomide may increase these risks along with possible blood clots.

Eligibility Criteria

Inclusion Criteria

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

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I have symptoms of multiple myeloma but no severe organ damage.

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I am 18 years old or older.

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I have been diagnosed with symptomatic multiple myeloma.

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My cancer can be measured by tests.

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

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I am not a candidate for, or have chosen not to undergo, a stem cell transplant during my first treatment.

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I am a man and will follow the required contraception guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

Characterization of genomic mutations of targetable genes

Characterization of immunomodulatory checkpoint pathways in multiple myeloma

overall response rate

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with Multiple MyelomaExperimental Treatment3 Interventions

This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 2

~1140

Dexamethasone

2007

Completed Phase 4

~2590

Lenalidomide

2005

Completed Phase 3

~1480

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,590 Total Patients Enrolled

80 Trials studying Multiple Myeloma

86,137 Patients Enrolled for Multiple Myeloma

Millennium Pharmaceuticals, Inc.Industry Sponsor

404 Previous Clinical Trials

46,884 Total Patients Enrolled

82 Trials studying Multiple Myeloma

10,032 Patients Enrolled for Multiple Myeloma

Hartford HospitalOTHER

133 Previous Clinical Trials

18,900 Total Patients Enrolled

Frequently Asked Questions

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

Is this study currently recruiting new participants?

"Unfortunately, the most recent update on clinicaltrials.gov suggests that this trial is not currently recruiting patients. This study was initially posted on August 1st, 2013 and was last updated on April 12th, 2022. However, there are 1592 other trials that are still enrolling individuals."

Answered by AI

In how many places is this experiment being done?

"Currently, there are seven operational sites for this trial: Memorial Sloan Kettering Cancer Center @ Suffolk in Commack; Memorial Sloan Kettering at Mercy Medical Center in Rockville Centre; and Memorial Sloan Kettering Westchester in Harrison. There are also four other locations."

Answered by AI

Is this the first time Bortezomib has been used in research?

"Bortezomib was studied for the first time in 2002 by Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. As of now, there have been a total of 1610 completed studies with 765 live trials. A large majority of these ongoing studies are based out of Commack, New york."

Answered by AI

Could you tell me about any potential risks associated with Bortezomib?

"Bortezomib's safety is only supported by preliminary data, so it was given a score of 2."

Answered by AI

Bortezomib is most commonly given to patients in order to ________.

"Bortezomib is typically used to treat ophthalmia, sympathetic. It can also be administered to treat various conditions such as at least two prior systemic chemotherapy regimens, branch retinal vein occlusion, macular edema."

Answered by AI

How many individuals are part of this research project?

"This study is no longer enrolling patients. The trial was initially posted on August 1st, 2013 and had its last update on April 12th, 2022. If you are seeking other studies, there are 827 trials for neoplasms, plasma cell and 765 studies involving Bortezomib that are currently recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma

2013. "Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01919086.

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