Daratumumab + VRd for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+152 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing if adding daratumumab to an existing three-drug treatment will improve outcomes for newly diagnosed multiple myeloma patients who are not planning a stem cell transplant. The combination of drugs works together to kill cancer cells in different ways. Daratumumab has shown efficacy in improving overall survival and progression-free survival in multiple myeloma patients when added to other treatment regimens.

Eligibility Criteria

This trial is for adults with untreated multiple myeloma who don't plan to have a stem cell transplant right away. They must have measurable disease, be able to perform daily activities (ECOG score 0-2), and women of childbearing age need two negative pregnancy tests before dosing. People can't join if they've had other cancer treatments or certain health conditions like severe neuropathy.

Inclusion Criteria

You must have a way for doctors to measure your disease using tests from a central laboratory.

A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing

A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the treatment regimen

+2 more

Exclusion Criteria

I have moderate to severe nerve pain or damage.

I have only used a short course of corticosteroids for my multiple myeloma.

I haven't had cancer, except for certain skin cancers or early-stage cervical or breast cancer, in the last 5 years.

+2 more

Participant Groups

The study is testing whether adding Daratumumab to the combination of Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) improves outcomes compared to just VRd in treating multiple myeloma. The main goal is seeing if this mix reduces the number of remaining cancer cells better than the standard combo.

2Treatment groups

Experimental Treatment

Active Control

Group I: Daratumumab + VRd (D-VRd) and DRdExperimental Treatment4 Interventions

Participants will receive daratumumab 1800 mg as SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3 through 8 and every 4 weeks for Cycle 9 and beyond; bortezomib 1.3 mg/m\^2 as SC injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9; dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond followed by daratumumab-lenalidomide-dexamethasone (DRd) until disease progression or unacceptable toxicity.

Group II: Bortezomib + Lenalidomide + Dexamethasone (VRd) and RdActive Control3 Interventions

Participants will receive bortezomib 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 (cycle of 28 days); dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond (each cycle is of 28 days) followed by lenalidomide-dexamethasone (Rd) until disease progression or unacceptable toxicity.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: