An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Daratumumab 16 mg/kg (Part 1) — DRUG
  Daratumumab 16 mg/kg administered at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter by intravenous infusion
• Daratumumab 8 mg/kg (Part 1) — DRUG
  Daratumumab 8 mg/kg every 4 weeks (Q4W) continuously by intravenous infusion
• Methylprednisolone — DRUG
  Administered in prophylactic doses intravenously (or equivalent in accordance with local standards) prior to and after study drug administration. Intravenous administration is preferred, but oral steroids may be substituted
• Acetaminophen — DRUG
  650 to 1000 mg administered in prophylactic doses by mouth prior to study drug administration.
• Diphenhydramine — DRUG
  25 to 50 mg administered in prophylactic doses by mouth (or equivalent in accordance with local standards) prior to and after study drug administration.
• Daratumumab (Part 2) — DRUG
  Based on the Part 1 response rate, Group A or B treatment will be selected as the treatment regimen for participants enrolled in Part 2.

Study Details

The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor \[PI\] and immunomodulatory drug \[IMiD\]) or are double refractory to a PI and an IMiD.

Key Dates

Start date

Sep 27, 2013

Status verified

Jun 2018

Primary completion

Jan 9, 2015

Completion

May 30, 2017

Study Design

Enrollment

124 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1
  During Stage 1 of Part 1, participants will be randomized to receive daratumumab treatment regimens in Group A and Group B. If in Stage 1, 1 or both of the treatment groups is considered to be ineffective and/or not well tolerated, then that treatment group will be terminated. Participants in Group B will be given the option to cross over to Group A if the investigator deems it in the best interest of the participants.
• Experimental: Part 2
  Based on the Part 1 response rate, Group A or B daratumumab treatment will be selected as the treatment regimen for participants enrolled in Part 2.

Primary Outcome Measure

Percentage of Participants With Overall Response [ Time Frame: Up to 14.4 Months ]

Locations (15)

Find similar trials in Duarte, CA

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