NCT03477539

Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma

Phase II Trial of Daratumumab for Transplant-Eligible Multiple Myeloma Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well daratumumab works in treating transplant-eligible patients with multiple myeloma. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

Detailed description

PRIMARY OBJECTIVE: I. To determine the percentage of patients achieving minimal residual disease (MRD) negativity by multiparameter flow cytometry (MPF) after autologous stem cell transplant (SCT) (at day 100) using pre-SCT daratumumab consolidation. SECONDARY OBJECTIVES: I. To determine percentage of patients achieving MRD negativity by MPF after 1 year of daratumumab+lenalidomide-based maintenance therapy. II. To determine progression-free survival (PFS) for peri-SCT treatment with daratumumab. III. To determine percentage of MRD negativity by MPF after pre-SCT consolidation with daratumumab. IV. To determine safety profile of peri-SCT daratumumab with lenalidomide. V. To determine the overall response rate (ORR) of patients receiving peri-SCT daratumumab for MM. VI. To determine the overall survival (OS) for patients receiving peri-SCT daratumumab for MM. OUTLINE: CONSOLIDATION I: Patients receive daratumumab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION II: Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo autologous stem cell transplant (ASCT). MAINTENANCE: Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide orally (PO) daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and every 3-6 months for up to 3 years.

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
PROCEDURE	Autologous Hematopoietic Stem Cell Transplantation	Undergo ASCT
BIOLOGICAL	Daratumumab	Given IV
DRUG	Lenalidomide	Given PO

Timeline

• Start date: 2018-04-09
• Primary completion: 2022-05-11
• Completion: 2025-03-24
• First posted: 2018-03-26
• Last updated: 2026-03-09
• Results posted: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study