A Phase I Open Label Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Administered in Combination With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Urelumab; Drug: Elotuzumab; Drug: Lirilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02252263

CA223-028

Details and patient eligibility

About

To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with either Lirilumab or Urelumab in subjects with multiple myeloma.

Full description

Allocation:

• Part1: Non-randomized
• Part2: Randomized

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Subjects must have histological confirmation of multiple myeloma with measurable disease (per International Myeloma Working Group (IMWG) criteria):

  • Relapsed/refractory multiple myeloma, subjects who are post autologous transplant and have achieved very good partial response (VGPR) or complete response (nCR) with minimal residual disease (MRD)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Arm 1: Elotuzumab + Lirilumab

Experimental group

Description:

Elotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response

Treatment:

Drug: Lirilumab

Drug: Elotuzumab

Arm 2: Elotuzumab + Urelumab

Experimental group

Description:

Elotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response

Treatment:

Drug: Elotuzumab

Drug: Urelumab