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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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02252263
Collaborator
(none)
44
Enrollment
7
Locations
2
Arms
34
Actual Duration (Months)
6.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Allocation:

  • Part1: Non-randomized

  • Part2: Randomized

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Dec 9, 2014
Actual Primary Completion Date :
Oct 10, 2017
Actual Study Completion Date :
Oct 10, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Elotuzumab + Lirilumab

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

Drug: Elotuzumab
Other Names:
  • BMS-901608

    • Drug: Lirilumab
    Other Names:
  • BMS-986015

    		•
    Experimental: Arm 2: Elotuzumab + Urelumab

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

    Drug: Elotuzumab
    Other Names:
  • BMS-901608

    • Drug: Urelumab
    Other Names:
  • BMS-663513

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [During treatment and first 100 days after treatment]

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

    Secondary Outcome Measures

    1. Best Overall Response (BOR) [At different timepoints approximately up to 2.5 years]

    2. Objective Response rate (ORR) [At different timepoints approximately up to 2.5 years]

    3. Median Duration of Response (mDOR) [At different timepoints approximately up to 2.5 years]

    4. Median Time to Response (mTTR) [At different timepoints approximately up to 2.5 years]

    5. Progression-free survival rate (PFSR) [At different timepoints approximately up to 2.5 years]

    6. M-protein levels [At different timepoints approximately up to 2.5 years]

    7. Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects [At different timepoints approximately up to 2.5 years]

    8. Maximum concentration of Urelumab (Cmax) [At different timepoints approximately up to 2.5 years]

    9. Maximum concentration of Lirilumab (Cmax) [At different timepoints approximately up to 2.5 years]

    10. Area under the Curve (AUCTAU) of Urelumab [At different timepoints approximately up to 2.5 years]

    11. Area under the Curve (AUCTAU) of Lirilumab [At different timepoints approximately up to 2.5 years]

    12. Volume of distribution (Vz) for Urelumab [At different timepoints approximately up to 2.5 years]

    13. Total Clearance (CLT) of Urelumab [At different timepoints approximately up to 2.5 years]

    14. Total Clearance (CLT) of Lirilumab [At different timepoints approximately up to 2.5 years]

    15. Concentration at the end of infusion (ceoinf) of Urelumab [At different timepoints approximately up to 2.5 years]

    16. Concentration at the end of infusion (ceoinf) of Elotuzumab [At different timepoints approximately up to 2.5 years]

    17. Concentration at the end of infusion (ceoinf) of Lirilumab [At different timepoints approximately up to 2.5 years]

    18. Cmin will be capture at steady state of all study subjects [At different timepoints approximately up to 2.5 years]

    19. Occurence of Specific anti-drug antibodies (ADA) to each study drug [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 [At different timepoints approximately up to 2.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Arkansas For Medical Sciences Little Rock Arkansas United States
    2 The Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland United States 21287
    3 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    4 The Ohio State University Columbus Ohio United States 43210
    5 Oregon Health & Science University Portland Oregon United States 97239
    6 University Of Pennsylvania Philadelphia Pennsylvania United States 19104
    7 Local Institution Pamplona Navarra Spain 31008

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02252263
    Other Study ID Numbers:
    • CA223-028
    First Posted:
    Sep 30, 2014
    Last Update Posted:
    Nov 1, 2017
    Last Verified:
    Oct 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Elotuzumab

    Study Results

    No Results Posted as of Nov 1, 2017