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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Elotuzumab; Drug: Lenalidomide; Drug: Dexamethasone

• Registration Number: NCT02159365
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-08
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-09
• Primary Completion: 2016-06-30
• Results First Submitted: 2016-11-15
• Results First Submitted QC: 2016-11-15
• Results First Posted: 2017-01-11
• Study Completion: 2018-07-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elotuzumab + Lenalidomide/Dexamethasone	Lenalidomide	Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
Elotuzumab + Lenalidomide/Dexamethasone	Dexamethasone	Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
Elotuzumab + Lenalidomide/Dexamethasone	Elotuzumab	Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab

Primary Outcome Measures

Name	Time	Method
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2	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 Outcome Measures

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

Trial Locations

Locations (29)

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

Highland Oncology Group; 🇺🇸 Fayetteville, Arkansas, United States

Comprehensive Blood And Cancer Center; 🇺🇸 Bakersfield, California, United States

California Cancer Associates for Research and Excellence; 🇺🇸 Encinitas, California, United States

Compassionate Cancer Res Grp; 🇺🇸 Fountain Valley, California, United States

Robert A. Moss, Md Facp, Inc.; 🇺🇸 Fountain Valley, California, United States

Loma Linda University Cancer Center; 🇺🇸 Loma Linda, California, United States

Pacific Cancer Care; 🇺🇸 Monterey, California, United States

Ventura County Hematology-Oncology Specialists; 🇺🇸 Oxnard, California, United States

Wellness Oncology & Hematology; 🇺🇸 West Hills, California, United States

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