Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma

Part of paid clinical trials in Monterey, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03236428
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Monoclonal Gammopathy
  • Smoldering Multiple Myeloma

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule

Study Details

This research study is studying a drug as a possible treatment for Monoclonal Gammopathy of Unknown Significance (MGUS) or Smoldering Multiple Myeloma (SMM). The drug involved in this study is: -Daratumumab

Key Dates

Start date
Nov 24, 2017
Status verified
Mar 2026
Primary completion
Oct 4, 2021
Completion
Oct 4, 2026

Study Design

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

Arms

  • Experimental: Daratumumab
    Daratumumab will be administered by IV infusion weekly during cycles 1 and 2 Daratumumab will be administered by IV infusion every other week during cycles 3 through 6 Daratumumab will be administered by IV infusion monthly during cycles 7 through 20

Primary Outcome Measure

The Proportion Of Patients In Deep Response [ Time Frame: 2 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
Pacific Cancer CareMontereyCalifornia93940-
Colorado Blood Cancer InstituteDenverColorado80218-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02214-
Karmanos Cancer InsituteDetroitMichigan48201-

Find similar trials in Monterey, CA

By research site
Pacific Cancer Care· Monterey, CAColorado Blood Cancer Institute· Denver, COBeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAKarmanos Cancer Insitute· Detroit, MI

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