NCT07085728

Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compared to the Usual Treatment of Cyclophosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients With Kidney Failure

A Randomized Phase II Trial Comparing Daratumumab-Bortezomib-Dexamethasone Versus Cyclophosphamide-Bortezomib-Dexamethasone in Newly Diagnosed Multiple Myeloma With Light Chain Cast Nephropathy (LCCN)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to answer the following question: Can the addition of daratumumab-hyaluronidase to the usual treatment of bortezomib and dexamethasone improve kidney function in patients who are newly diagnosed with multiple myeloma and have kidney failure? This study is being done because the investigators want to find out if this approach is better or worse than the usual approach for the participant's newly diagnosed multiple myeloma. The usual approach is defined as care most people get for multiple myeloma. If the participant decides to take part in this study, they will either get the study medications daratumumab-hyaluronidase, bortezomib, and dexamethasone for four months (4 cycles), or the typical medications used to treat your cancer (cyclophosphamide, bortezomib, and dexamethasone) for 4 months (4 cycles). After the participant finishes their study treatment, their doctor will continue to follow their condition for 10 years to watch them for side effects and monitor their disease status. Their doctor will follow up with them every 3 months for years 1 and 2 and then every 6 months for years 3 through 10.

Detailed description

2.1 Primary Objectives 2.1.1 To determine whether incorporation of daratumumab-hyaluronidase into the treatment algorithm for newly diagnosed light chain cast nephropathy (LCCN) will improve efficacy measured by renal response rates (RRR) per International Myeloma Working Group (IMWG) renal response criteria over 4 cycles of treatment. 2.2 Secondary Objectives 2.2.1 To evaluate the safety profile of daratumumab-hyaluronidase replacing cyclophosphamide in combination with bortezomib and dexamethasone and to compare treatment-related grades 3-5 adverse event rates based on CTCAE criteria 2.2.2 To evaluate the myeloma response per IMWG uniform response criteria over 4 cycles of therapy 2.2.3 To evaluate progression-free and overall survival 2.3 Exploratory Objectives 2.3.1 To characterize renal function over time 2.3.2 To assess stem cell mobilization initiation and collection yield in patients eligible for autologous stem cell transplant (ASCT) who undergo mobilization 2.3.3 To assess rate of eligible patients undergoing ASCT 2.3.4 To assess treatment exposure and adherence 2.3.5 To assess the association of renal impairment stage at baseline and renal response with survival outcomes

Conditions

• Myeloma Multiple

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Arm A
DRUG	Bortezomib (VELCADE)	Arm A, Arm B
DRUG	Dexamethasone	Arm A, Arm B
DRUG	Daratumumab-hyaluronidase	Arm B

Timeline

• Start date: 2025-08-11
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-07-25
• Last updated: 2025-08-22