Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

Relapsed and/or Refractory Multiple Myeloma Clinical Trial

Official title:

Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01632150
• Other study ID #: CA204-010
• Secondary ID: 2011-005121-49
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 28, 2012
• Last updated: January 29, 2016
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of elotuzumab administered in combination with thalidomide and dexamethasone in the treatment of relapsed and/or refractory multiple myeloma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: December 2016
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Key Inclusion Criteria:

• Confirmed diagnosis of previously treated multiple myeloma with progression documented by criteria of the International Myeloma Working Group after or during the most recent therapy

• Patient received 5 or fewer prior lines of therapy

• Eastern Cooperative Oncology Group performance status of 0 or 1 (safety lead-in cohort) or 0 to 2 (additional patients)

• Measurable disease as defined by at least 1 of the following:

• Serum immunoglobulin (Ig)G, IgA, IgM, or monoclonal (M) protein level =0.5 g/dL or serum IgD M protein level =0.05 g/dL; or

• Urine M protein level =200 mg excreted in a 24-hour collection sample; or

• Involved serum free light chain level =10 mg/dL, provided the free light chain ratio is abnormal

Key Exclusion Criteria:

• Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia

• Monoclonal gammopathy of undetermined significance, smoldering myeloma, or Waldenström's macroglobulinemia

• Left ventricular ejection fraction by echocardiogram or Multi Gated Acquisition =50%

• Electrocardiogram finding of QTc =450 msec

• Active plasma cell leukemia (defined as either 20% of peripheral white blood cells, composed of plasma/CD138+ cells or an absolute plasma cell count of 2*10^9/L)

• Diagnosis of nonsecretory myeloma

• Active hepatitis A, B, or C virus infection

• Grade =2 neuropathy

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed and/or Refractory Multiple Myeloma

Intervention

Biological:
• Elotuzumab
Powder for solution, 400-mg vials, for infusion
• Thalidomide
50-mg capsules administered orally
• Dexamethasone
2- and 4-mg tablets (and various other strengths, as needed) administered orally and in 4- and 8-mg/mL (and various other strengths, as needed) solutions for intravenous administration
• Cyclophosphamide
50-mg tablets administered orally

Locations

Country	Name	City	State
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	LaLaguna, S Cruz Tener
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Salamanca
Spain	Local Institution	Sevilla
Spain	Local Institution	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	AbbVie

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.	Day 1 of treatment through 19 months	Yes
Primary	Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.	Day 1 of treatment through 19 months	Yes
Secondary	Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event	Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. Cyclophosphamide dose reduction, delay, interruption, or discontinuation was permitted in the event of toxicity.	Day 1 of treatment through 19 months	Yes
Secondary	Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event	Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator.	Day 1 of treatment through 19 months	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form