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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Upper arm
Upper arm
Secondary outcome measures
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
~2590
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,301 Total Patients Enrolled
19 Trials studying Multiple Myeloma
7,067 Patients Enrolled for Multiple Myeloma
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,660 Total Patients Enrolled
19 Trials studying Multiple Myeloma
7,067 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,925,931 Total Patients Enrolled
581 Trials studying Multiple Myeloma
188,691 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

Frequently Asked Questions

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

Has the regulatory body approved Arm II (DRd-R) for public use?

"Our team at Power believes Arm II (DRd-R) is fairly safe, as it has achieved a score of 3 after multiple rounds of data collection that have shown both efficacy and safety."

Answered by AI

Are there any openings for volunteers in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively enrolling participants and was first posted on June 1st 2023; the last edit was made May 30th 2023. 510 patients are required from a single location."

Answered by AI

What are the desired outcomes of this experiment?

"This 10-year clinical trial intends to measure overall survival (OS) between two study arms. As well, progression-free survival (PFS), patient report outcomes (PRO), quality of life (QOL) and minimal residual disease (MRD) will also be evaluated through stratified log rank test, EORTC QLQ-C30 v3 questionnaire, and binomial tests respectively."

Answered by AI

How many human subjects are participating in this trial?

"Affirmative, the information on clinicaltrials.gov testifies that this investigation is actively accepting enrollees. The trial was initially posted on June 1st 2023 and has been revised recently on May 30th 2023. Presently there are 510 participants being recruited from a single site."

Answered by AI

Who else is applying?

What site did they apply to?
Saint Francis Cancer Center
Harrison Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Trying to consider all options.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
2023. "Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05561387.
All > Toronto > Fargo
~340 spots leftby Mar 2030
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