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Proteasome Inhibitor

Drug Combinations for Multiple Myeloma

Phase 3

Recruiting

Led By Sikander Ailawadhi

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

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

Must have

All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration

Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2

Must not have

Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration

Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial studies 3 treatment combos of 4 drugs to find best way to treat newly diagnosed multiple myeloma.

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who are not suitable for stem cell transplant due to age or health issues. They must have measurable disease, adequate organ function, and no severe neuropathy or other cancers that could affect the study. Pregnant individuals can't participate, and those of reproductive potential must use contraception.

What is being tested?

The trial compares three drug combinations as initial treatment followed by maintenance therapy in frail or intermediate-fit patients with multiple myeloma. It tests Bortezomib, Lenalidomide, Dexamethasone, and Daratumumab/Hyaluronidase-fihj to find which regimen best controls the cancer.

What are the potential side effects?

Potential side effects include nerve damage (neuropathy), blood clots, low blood counts leading to increased infection risk or bleeding problems, fatigue, allergic reactions to monoclonal antibodies like daratumumab/hyaluronidase-fihj and steroid-related issues such as high blood sugar from dexamethasone.

Eligibility Criteria

Inclusion Criteria

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

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I have chronic hepatitis B but it's undetectable with treatment.

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I can take care of myself and am up and about more than half of the day.

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I have kidney problems but am not on dialysis.

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My blood or urine tests show signs of multiple myeloma.

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My myeloma frailty score is either frail or intermediate.

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I had hepatitis C but have been treated and cured.

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My condition is at stage III according to the R-ISS.

Exclusion Criteria

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

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I do not have severe nerve damage in my hands or feet.

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I do not have another cancer that could affect this treatment's safety or results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Upper arm

Secondary study objectives

Neoplasm, Residual

Overall response rate (ORR)

+6 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

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (DRd-DR):Experimental Treatment5 Interventions

INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (DRd-R)Experimental Treatment5 Interventions

INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (VRd-Lite)Active Control5 Interventions

INDUCTION CYCLES 1-9: Patients receive bortezomib SC on days 1, 8, 15, and 22 of each cycle, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days 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

~2650

Lenalidomide

2005

Completed Phase 3

~2240