NCT04352205

Daratumumab-Based Therapy for the Treatment of Newly Diagnosed Multiple Myeloma With Kidney Failure

A Phase 2 Evaluation of Daratumumab-Based Treatment in Newly Diagnosed Multiple Myeloma Patients With Renal Insufficiency

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well daratumumab-based therapy works in treating patients with newly diagnosed multiple myeloma with kidney failure. Daratumumab-based therapy includes daratumumab, bortezomib, dexamethasone, and thalidomide or lenalidomide. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Bortezomib is a drug that prevents myeloma cells from getting rid of their waste products, leading to being targeted for death. Dexamethasone is a steroid that is commonly used, either alone or in combination with other drugs, to treat multiple myeloma. Lenalidomide and thalidomide may stop the growth of multiple myeloma by blocking the growth of new blood vessels necessary for tumor growth. Giving daratumumab, bortezomib, dexamethasone, and thalidomide or lenalidomide may be a good way to treat patients with newly diagnosed multiple myeloma with kidney failure.

Detailed description

PRIMARY OBJECTIVE: I. To determine the proportion of patients with newly diagnosed myeloma and acute kidney injury (AKI) who have renal function recovery following 2 cycles (6 weeks) of treatment with a daratumumab-based induction regimen. SECONDARY OBJECTIVES: I. Overall response rate at the end of 2 and 4 cycles of therapy. II. Adverse event profile of the combination in patients with AKI. III. Pharmacokinetic parameters of maximum concentration (Cmax), area under the curve (AUC), time to maximum concentration (tmax), clearance, and half life (t1/2) of daratumumab in combination treatment in the AKI population. IV. Global assessment of renal function at cycle initiation including creatinine clearance (CrCl). V. Timeline of changes in pharmacodynamic markers of light chains, urine paraprotein, and serum paraprotein measures. OUTLINE: Patients receive daratumumab intravenously (IV) weekly of cycles 1-3 and on day 1 only of cycle 4, bortezomib subcutaneously (SC) on days 1, 4, 8, and 11, and dexamethasone IV or orally (PO) on days 1-4 of cycle 1 and on day 1 of cycles 2-4 and PO on days 8 and 15 of all cycles. Beginning cycle 2, patients may also receive lenalidomide PO daily on days 1-14 or thalidomide PO once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Plasma Cell Myeloma
• Renal Failure

Interventions

Type	Name	Description
DRUG	Bortezomib	Given SC
BIOLOGICAL	Daratumumab	Given IV
DRUG	Dexamethasone	Given PO and IV
DRUG	Lenalidomide	Given PO
DRUG	Thalidomide	Given PO

Timeline

• Start date: 2020-05-07
• Primary completion: 2024-01-19
• Completion: 2024-01-19
• First posted: 2020-04-20
• Last updated: 2024-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study