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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04991103
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DaraVRD/DaraVCD — DRUG
    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).

Study Details

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).

Key Dates

Start date
Sep 22, 2021
Status verified
Dec 2025
Primary completion
Jan 1, 2027
Completion
Aug 27, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab, Bortezomib, Dexamethasone with Lenalidomide/Cyclophosphamide
    Quadruplet therapy in the treatment of newly diagnosed myeloma and AL amyloidosis

Primary Outcome Measure

Number of patients who are able to attain MRD<10-5 by next generation sequencing after 6 cycles of Dara-VRD and defer AHCT. [ Time Frame: Baseline through 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Luciano J Costa, MD, PhD
[email protected]
205-934-1908
Susan Bal, MD (PRINCIPAL_INVESTIGATOR)
Luciano J Costa, MD, PhD (SUB_INVESTIGATOR)
Kelly Godby, MD (SUB_INVESTIGATOR)
Gayathri Ravi, MD (SUB_INVESTIGATOR)
Heidi Worth, MD (SUB_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Alabama at Birmingham· Birmingham, AL

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