A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Daratumumab — DRUG
  For induction therapy cycle 1 day 1 and day 2 doses of daratumumab will be 8 milligram/kilogram (mg/kg). Starting cycle 1 week 2 until the completion of week 8 of daratumumab patients will receive 16 mg/kg Intravenously (IV) weekly. Starting week 9 until the completion of week 24 therapy daratumumab will be administered every other week at 16 mg/kg IV. Starting week 25 and beyond for induction therapy daratumumab will be given once every 4 weeks.
• Cyclophosphamide — DRUG
  Subjects will receive 4 to 8 cycles of oral cyclophosphamide 300 milligram per meter square (mg/m\^2 ) on Days 1, 8, 15, and 22 for every 28 days.
• Bortezomib — DRUG
  Subjects will receive 4 to 8 cycles of Bortezomib 1.5 mg/m2 subcutaneous (SC) on Days 1, 8, and 15 for every 28 days.
• Dexamethasone — DRUG
  Subjects will be given corticosteroids (Dexamethasone) as pre-infusion therapy prior to daratumumab and for the first 8 cycles will also receive post-infusion corticosteroids (Dexamethasone).

Study Details

The purpose of this study is to evaluate complete response plus (+) very good partial response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in previously untreated subjects, and in relapsed subjects with multiple myeloma, as defined by the International Myeloma Working Group (IMWG) criteria.

Key Dates

Start date

Nov 9, 2016

Status verified

Oct 2021

Primary completion

Mar 8, 2018

Completion

Aug 17, 2020

Study Design

Enrollment

101 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dara-CyBorD
  Subjects will receive Daratumumab along with Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) as induction on a 28-day cycle length and Daratumab and Dexamethasone on Day 1 of each cycle for 12 cycles as maintenance therapy.

Primary Outcome Measure

Percentage of Participants Who Achieved Complete Response (CR) or Very Good Partial Response (VGPR) [ Time Frame: After 4 cycles of Induction (Approximately 4 months) ]

Locations (26)

Find similar trials in Mobile, AL

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