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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


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
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