Skip to main content
OpenTrials
Completed

NCT Number: NCT02252263

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Pamplona, Navarre, Spain

Loading trial locations.

About this study

Allocation:

  • Part1: Non-randomized
  • Part2: Randomized

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Elotuzumab

Drug

Other names: BMS-901608

Lirilumab

Drug

Other names: BMS-986015

Urelumab

Drug

Other names: BMS-663513

Primary outcomes

  1. Safety as measured by the rate of AEs, SAEs, deaths is the primary endpoint of this Phase 1 study. All subjects who receive at least one (full or partial) dose of Elotuzumab, Lirilumab or Urelumab will be evaluated for safety

    Time frame: During treatment and first 100 days after treatment

    adverse events (AEs), serious adverse events (SAEs)

Secondary outcomes

  1. Best Overall Response (BOR)

    Time frame: At different timepoints approximately up to 2.5 years

  2. Objective Response rate (ORR)

    Time frame: At different timepoints approximately up to 2.5 years

  3. Median Duration of Response (mDOR)

    Time frame: At different timepoints approximately up to 2.5 years

  4. Median Time to Response (mTTR)

    Time frame: At different timepoints approximately up to 2.5 years

  5. Progression-free survival rate (PFSR)

    Time frame: At different timepoints approximately up to 2.5 years

  6. M-protein levels

    Time frame: At different timepoints approximately up to 2.5 years

  7. Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects

    Time frame: At different timepoints approximately up to 2.5 years

  8. Maximum concentration of Urelumab (Cmax)

    Time frame: At different timepoints approximately up to 2.5 years

  9. Maximum concentration of Lirilumab (Cmax)

    Time frame: At different timepoints approximately up to 2.5 years

  10. Area under the Curve (AUCTAU) of Urelumab

    Time frame: At different timepoints approximately up to 2.5 years

  11. Area under the Curve (AUCTAU) of Lirilumab

    Time frame: At different timepoints approximately up to 2.5 years

  12. Volume of distribution (Vz) for Urelumab

    Time frame: At different timepoints approximately up to 2.5 years

  13. Total Clearance (CLT) of Urelumab

    Time frame: At different timepoints approximately up to 2.5 years

  14. Total Clearance (CLT) of Lirilumab

    Time frame: At different timepoints approximately up to 2.5 years

  15. Concentration at the end of infusion (ceoinf) of Urelumab

    Time frame: At different timepoints approximately up to 2.5 years

  16. Concentration at the end of infusion (ceoinf) of Elotuzumab

    Time frame: At different timepoints approximately up to 2.5 years

  17. Concentration at the end of infusion (ceoinf) of Lirilumab

    Time frame: At different timepoints approximately up to 2.5 years

  18. Cmin will be capture at steady state of all study subjects

    Time frame: At different timepoints approximately up to 2.5 years

  19. Occurence of Specific anti-drug antibodies (ADA) to each study drug

    Time frame: At different timepoints approximately up to 2.5 years

  20. ADA status of the subject Biomarkers: NK and T cell numbers, Phenotypic and functional measures in cohort expansion subjects

    Time frame: At different timepoints approximately up to 2.5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase I Open Label Dose Escalation and Randomized Cohort Expansion 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2014
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.