# 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

> **NCT01985126** · PHASE2 · COMPLETED · sponsor: **Janssen Research & Development, LLC** · enrollment: 124 (actual)

## Conditions studied

- Multiple Myeloma

## Interventions

- **DRUG:** Daratumumab 16 mg/kg (Part 1)
- **DRUG:** Daratumumab 8 mg/kg (Part 1)
- **DRUG:** Methylprednisolone
- **DRUG:** Acetaminophen
- **DRUG:** Diphenhydramine
- **DRUG:** Daratumumab (Part 2)

## Key facts

- **NCT ID:** NCT01985126
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-09-27
- **Primary completion:** 2015-01-09
- **Final completion:** 2017-05-30
- **Target enrollment:** 124 (ACTUAL)
- **Last updated:** 2018-06-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01985126

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01985126, "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". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT01985126. Licensed CC0.

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