RecruitingPhase 2NCT04991103

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

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


Sponsor

University of Alabama at Birmingham

Enrollment

40 participants

Start Date

Sep 22, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (MILESTONE) looks at whether patients with newly diagnosed multiple myeloma (a blood cancer) who achieve a very deep remission can safely delay or avoid a stem cell transplant by monitoring a measure of remaining disease called minimal residual disease (MRD). **You may be eligible if...** - You are 18 or older with newly diagnosed multiple myeloma requiring treatment - You have measurable disease (confirmed by specific lab tests) - You have adequate liver and kidney function - You are potentially eligible for a stem cell transplant per your doctor's assessment - You are willing to follow study requirements including contraception during treatment **You may NOT be eligible if...** - You have POEMS syndrome or Waldenstrom's macroglobulinemia - You have recently had surgery, major radiation, or serious infection - You are pregnant or breastfeeding - You have uncontrolled HIV, hepatitis B, or hepatitis C - You have severe heart disease or a recent heart attack (within 4 months) - You have had a stroke within the past year - You have significant nerve damage (neuropathy grade 3–4) - You have another active cancer (outside of certain limited exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaraVRD/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).


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT04991103


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