Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant

Part of paid clinical trials in Tampa, Florida.

Sponsor
International Myeloma Foundation
Study ID
NCT03289299
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Smoldering Multiple Myeloma

Eligibility Criteria

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

Interventions

  • Carfilzomib — DRUG
    56 mg/m2 IV given on days 1, 8, and 15 of each cycle during induction and consolidation phases of the study.
  • Lenalidomide — DRUG
    25 mg po given on days 1-21 of each cycle during the induction and consolidation phases. 10 mg po given on days 1-21 of each cycle during the maintenance phase.
  • Daratumumab — DRUG
    16 mg/kg IV given on days 1, 8, 15, and 22 of cycles 1-2; days 1 and 15 of cycles 3-6; day 1 of cycle 7-12; Day 1 of odd cycles for cycles 13-24.
  • Dexamethasone — DRUG
    40 mg oral given on days 1, 8, 15, and 22 of cycles 1-6 20 mg oral given on days 1, 8, 15, and 22 of cycles 7-12

Study Details

This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.

Key Dates

Start date
May 25, 2018
Status verified
Dec 2023
Primary completion
Sep 26, 2023
Completion
Nov 15, 2031

Study Design

Enrollment
87 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Non-high dose treatment in 3 phases Induction 6 cycles: carfilzomib, lenalidomide, daratumumab, dexamethasone Consolidation 6 cycles: carfilzomib, lenalidomide, daratumumab, dexamethasone Maintenance 12 cycles: lenalidomide, daratumumab

Primary Outcome Measure

Stringent complete response rate [ Time Frame: During treatment ]

Locations (10)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
University of Chicago Medical CenterChicagoIllinois60637-
Indiana University Simon Cancer CenterIndianapolisIndiana46202-
University of Kansas Cancer CenterWestwoodKansas66205-
University of Maryland Medical CenterBaltimoreMaryland21201-
Mayo ClinicRochesterMinnesota55905-
Weill Cornell MedicineNew YorkNew York10022-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Swedish Cancer InstituteSeattleWashington98104-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLUniversity of Chicago Medical Center· Chicago, ILIndiana University Simon Cancer Center· Indianapolis, INUniversity of Kansas Cancer Center· Westwood, KSUniversity of Maryland Medical Center· Baltimore, MDMayo Clinic· Rochester, MN

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