Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

October 5, 2020

Primary Completion Date

May 2, 2024

Study Completion Date

May 2, 2026

Conditions
Multiple Myeloma
Interventions
DRUG

Daratumumab

"Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).~Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36)~Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88)~Sites will continue to use IV daratumumab to treat existing study patients until the IV daratumumab stock on site has been exhausted. The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab.~Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1"

DRUG

Lenalidomide

"Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24)~Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36)~Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance~Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression"

DRUG

Bortezomib

Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36)

DRUG

Dexamethasone

Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly

Trial Locations (4)

14642

University of Rochester, Rochester

48109

University of Michigan Rogel Cancer Center, Ann Arbor

48201

Barbara Ann Karmanos Cancer Institute, Detroit

75390

University of Texas Southwestern -- Simmons Comprehensive Cancer Center, Dallas

All Listed Sponsors
collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

lead

University of Michigan Rogel Cancer Center

OTHER