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OpenTrials
Completed

NCT Number: NCT02159365

Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients

To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.

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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 2

Primary location

Acrc/Arizona Clinical Research Center, Inc., Tucson, Arizona, United States

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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

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Documented evidence of active multiple myeloma:
  • Newly diagnosed, not candidate for transplant
  • Relapsed/refractory who have received up to 3 prior lines of therapy
  • Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:
  • Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide
  • Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)

Exclusion criteria

  • Target Disease Exceptions
  • Plasma cell leukemia
  • Monoclonal gammopathy of undetermined significance (MGUS)
  • Smoldering Myeloma
  • Primary amyloidosis
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome

Treatment and study plan

Elotuzumab

Drug

Other names: BMS-901608

Lenalidomide

Drug

Other names: Revlimid

Dexamethasone

Drug

Primary outcomes

  1. Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2

    Time frame: From Day 1 to End of cycle 2 treatment (approximately 56 days)

    Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.

Secondary outcomes

  1. Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period

    Time frame: Date of first dose up to 60 days post last dose (approximately 4 years)

    An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 2 Single Arm Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jun 9, 2014
Registry last updated
Jul 16, 2019

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.

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