NCT01592370

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.

Detailed description

NOTE: Currently, this study is only open to nivolumab+daratumumab vs daratumumab monotherapy in multiple myeloma patients.

Conditions

• Non-Hodgkin's Lymphoma
• Hodgkin Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Administered by intravenous (IV) infusion
BIOLOGICAL	Ipilimumab	Administered by IV infusion
BIOLOGICAL	Lirilumab	Administered by IV infusion
BIOLOGICAL	Daratumumab	Administered by IV infusion
DRUG	Pomalidomide	Administered PO
DRUG	Dexamethasone	Administered PO and by IV infusion

Timeline

• Start date: 2012-08-02
• Primary completion: 2020-09-25
• Completion: 2024-07-09
• First posted: 2012-05-07
• Last updated: 2025-10-22
• Results posted: 2022-02-17

Locations

43 sites across 6 countries: United States, Belgium, France, Greece, Italy, Poland

Regulatory

• FDA-regulated drug study