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Proteasome Inhibitor

Daratumumab-Based Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Led By Rachid C Baz, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Calculated creatinine clearance >/=30ml/min by Cockcroft-Gault formula

Eastern Cooperative Group (ECOG) Performance Status of 0 - 2

Must not have

Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia

Known allergy or hypersensititvity or intolerance to any of the study drugs, hyaluronidase, monocolonal antibodies (mAbs), human proteins, or their excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing daratumumab-based therapies for older adults with multiple myeloma.

Who is the study for?

This trial is for older adults (65+) with newly diagnosed multiple myeloma who haven't had chemotherapy but may have had palliative radiotherapy or a small dose of dexamethasone. They must be able to follow the study schedule, use contraception if necessary, and have adequate organ function and bone marrow capacity. People with severe other illnesses, active infections requiring IV antibiotics, certain viral infections (HIV, hepatitis B/C), or uncontrolled medical conditions are excluded.

What is being tested?

The study tests daratumumab-based therapies combined with oral dexamethasone, lenalidomide pills, and bortezomib injections in treating multiple myeloma in older adults. It's designed to see how well patients respond to this combination therapy without undergoing high-dose chemotherapy with stem-cell transplantation due to their age or coexisting conditions.

What are the potential side effects?

Potential side effects include reactions at the injection site for daratumumab and bortezomib; increased risk of infection; blood clots; fatigue; nausea; diarrhea from lenalidomide and dexamethasone; as well as possible liver toxicity indicated by changes in blood tests.

Eligibility Criteria

Inclusion Criteria

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

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My kidneys are functioning well enough, as per a specific test.

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I am able to get out of my bed or chair and move around.

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My blood tests show I have enough white blood cells and platelets.

Exclusion Criteria

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

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My only sign of plasma cell disorder is a single bone or soft tissue tumor.

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I am not allergic to the study drugs, hyaluronidase, monoclonal antibodies, human proteins, or their components.

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I am currently receiving IV antibiotics for a severe infection.

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I do not have unmanaged health issues like heart disease, high blood pressure, or diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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 Response Rate

Secondary study objectives

Overall Survival

Progression Free Survival

Other study objectives

Number of Participants who Continue on Arm A after 2 cycles

Number of Participants without Minimal Residual Disease

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: C: Daratumumab, Dexamethasone and BortezomibExperimental Treatment3 Interventions

Participants who have less than a partial response to Arm A may have Bortezomib added to their treatment. Bortezomib will be given weekly in subcutaneous injections at a starting dose of 1/3 mg/m\^2 Days 1,8 and 15 of each 28 day treatment cycle.

Group II: B: Daratumumab, Dexamethasone and LenalidomideExperimental Treatment3 Interventions

Participants who have less than a partial response to Arm A may have Lenalidomide added to their treatment. Lenalidomide will be given orally on days 1-21 of each 28 day treatment cycle.

Group III: A: Daratumumab & DexamethasoneExperimental Treatment2 Interventions

All participants will receive 1800 mg in 15 ml Daratumumab by subcutaneous injection weekly and be given 20 mg of Dexamethasone orally once a week for 2 months. Patients who receive a partial response or better will continue on this arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone Oral

2020

N/A

~14110

Bortezomib Injection

2018

Completed Phase 2

~460