A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)

Part of paid clinical trials in Anaheim, California.

Sponsor
Takeda
Study ID
NCT03439293
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ixazomib — DRUG
    Ixazomib capsule.
  • Daratumumab — DRUG
    Daratumumab IV infusion.
  • Dexamethasone — DRUG
    Dexamethasone tablets.

Study Details

The purpose of this study is to evaluate the percentage of participants with a response of very good partial response (VGPR) or better to IDd treatment.

Key Dates

Start date
Mar 13, 2018
Status verified
Jun 2024
Primary completion
Jan 1, 2022
Completion
Jun 26, 2023

Study Design

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

Arms

  • Experimental: Ixazomib 4 mg + Daratumumab 16 mg/kg + Dexamethasone 20 mg
    Ixazomib, 4 mg, capsules, orally, on Days 1, 8 and 15 of each 28-day cycle along with daratumumab, 16 mg/kg, intravenously (IV), on Days 1, 8, 15 and 22 of Cycles 1 and 2, on Days 1 and 15 (every 2 weeks) for Cycles 3 to 6 and on Day 1 (every 4 weeks) for Cycle 7 and beyond along with dexamethasone, 20 mg, tablets, orally on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or up to 5 years.

Primary Outcome Measure

Percentage of Participants With Very Good Partial Response (VGPR) or Better (Complete Response + VGPR) [ Time Frame: Up to 5 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
Pacific Cancer Medical CenterAnaheimCalifornia92801-
Colorado Blood Cancer InstituteDenverColorado80218-
SCRI - Florida Cancer Specialists - PanhandleTallahasseeFlorida32308-
Research Medical Center - Kansas CityKansas CityMissouri64132-
SCRI - Tennessee Oncology - Nashville - CentennialNashvilleTennessee58014-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Anaheim, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Pacific Cancer Medical Center· Anaheim, CAColorado Blood Cancer Institute· Denver, COSCRI - Florida Cancer Specialists - Panhandle· Tallahassee, FLResearch Medical Center - Kansas City· Kansas City, MOSCRI - Tennessee Oncology - Nashville - Centennial· Nashville, TNThe University of Texas MD Anderson Cancer Center· Houston, TX

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