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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

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 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
Upper arm
Secondary study objectives
Neoplasm, Residual
OS
Overall response rate (ORR)
+6 more

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
~2640
Lenalidomide
2005
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,677 Total Patients Enrolled
19 Trials studying Multiple Myeloma
7,067 Patients Enrolled for Multiple Myeloma
SWOG Cancer Research NetworkLead Sponsor
395 Previous Clinical Trials
264,564 Total Patients Enrolled
19 Trials studying Multiple Myeloma
7,067 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,490 Total Patients Enrolled
590 Trials studying Multiple Myeloma
188,847 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05561387 — Phase 3
Multiple Myeloma Research Study Groups: Arm II (DRd-R), Arm I (VRd-Lite), Arm III (DRd-DR):
Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT05561387 — Phase 3
Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05561387 — Phase 3
~340 spots leftby Mar 2030
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