NCT04991103

Minimal Residual Disease Response-adapted Deferral of Transplant in Dysproteinemia (MILESTONE)

Minimal Residual Disease Response-adapted Deferral of Transplant in Dysproteinemia - MILESTONE Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II interventional study evaluating the use of minimal residual disease by next generation sequencing to defer autologous hematopoietic stem cell transplantation (AHCT) in patients with newly diagnosed multiple myeloma (cohort A) and amyloidosis (cohort B).

Detailed description

While AHCT is an important treatment strategy for patients with plasma cell disorders, from a safety standpoint, AHCT is associated with both acute toxicities that reduce quality of life and long-term toxicities that may limit life expectancy for some patients. Additionally its benefit in patients without evidence of minimal residual disease (MRD) is unknown. We propose to examine MRD response as a strategy to defer AHCT in a systematic manner.

Conditions

• Multiple Myeloma
• Amyloidosis

Interventions

Type	Name	Description
DRUG	DaraVRD/DaraVCD	Patients in Cohort A with newly diagnosed multiple myeloma will receive six cycles of combination quadruplet therapy (DaraVRD). Six 28-day induction cycles of oral lenalidomide (25 mg daily on days 1-21), subcutaneous bortezomib (1.3 mg/m2 on days 1, 8, 15, 22), subcutaneous daratumumab (1800 mg on days 1, 8, 15, 22 of cycles 1-2 and days 1, 15 for cycles 3-6), and oral dexamethasone (40 mg on days 1, 8, 15, and 22). Patients in Cohort B with newly diagnosed amyloidosis will receive six cycles of combination quadruplet therapy (DaraVCD). Six 28-day induction cycles of IV cyclophosphamide (300 mg/m2 on days 1, 8, 15, 22), subcutaneous bortezomib (1.3 mg/m2 on days 1, 8, 15, 22), subcutaneous daratumumab (1800 mg on days 1, 8, 15, 22 of cycles 1-2 and days 1, 15 for cycles 3-6), and oral dexamethasone (40 mg on days 1, 8, 15, and 22).

Timeline

• Start date: 2021-09-22
• Primary completion: 2027-01-01
• Completion: 2028-08-27
• First posted: 2021-08-05
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study