DARA RVD For High Risk SMM

Part of paid clinical trials in Stamford, Connecticut.

Sponsor
Omar Nadeem, MD
Study ID
NCT04775550
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Daratumumab — DRUG
    Subcutaneous, dosage per protocol, dose days vary per cycle. Cycle =28 days
  • Bortezomib — DRUG
    Subcutaneous, dosage per protocol, dose days vary per cycle. Cycle =28 days
  • Lenalidomide — DRUG
    Oral, dosage per protocol, days 1-21 per cycle
  • Dexamethasone — DRUG
    Oral, dosage per protocol, dose days vary per cycle. Cycle =28 days

Study Details

The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. The names of the study drugs involved in this study are: * Daratumumab (also called Darzalex Faspro) * Bortezomib (also called Velcade) * Lenalidomide (also called Revlimid) * Dexamethasone

Key Dates

Start date
Mar 8, 2021
Status verified
Jun 2025
Primary completion
Dec 20, 2026
Completion
Dec 8, 2030

Study Design

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

Arms

  • Experimental: Daratumumab, Bortezomib,Lenalidomide,Dexamethasone
    The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Cycle Length is 28 days. The names of the study drugs involved in this study are: * Daratumumab * Bortezomib * Lenalidomide * Dexamethasone

Primary Outcome Measure

Proportion of high risk smoldering multiple myeloma (SMM) patients who are MRD negative (MRD-) [ Time Frame: 2 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
Stamford HospitalStamfordConnecticut06902-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Dana-Farber Brigham Cancer Center - FoxboroughFoxboroughMassachusetts02035-
Dana-Farber Cancer Institute - Merrimack ValleyMethuenMassachusetts01844-
Dana-Farber Brigham Cancer CenterSouth WeymouthMassachusetts02190-

Find similar trials in Stamford, CT

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Stamford Hospital· Stamford, CTBrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MADana-Farber Brigham Cancer Center - Foxborough· Foxborough, MADana-Farber Cancer Institute - Merrimack Valley· Methuen, MADana-Farber Brigham Cancer Center· South Weymouth, MA

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