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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

Must not have

Patients who have received any non-protocol therapy outside of the assigned induction therapy including stem cell transplant

Nursing women

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received treatments outside of my assigned therapy, including stem cell transplant.

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I am currently breastfeeding.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS) for the maintenance analysis

Progression-free survival for the induction analysis

Secondary study objectives

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 study objectives

Change in gene expression levels

Change in mutation status

Circulating plasma cells and plasma cell proliferation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 3

~1410

Carfilzomib

2017

Completed Phase 3

~1430