Back to results

Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Elotuzumab

Bortezomib

Dexamethasone

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapsed/Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Documented progression from most recent line of therapy
Measurable disease
1 to 3 prior lines of therapy
- Subjects may be proteasome inhibitor naive or have received prior proteasome inhibitor therapy provided all the following criteria are met:
  1. The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity
  2. The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose
  3. The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI)

Exclusion Criteria:

Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or Waldenstrom's macroglobulinemia
Active plasma cell leukemia
Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Elotuzumab + Bortezomib + Dexamethasone

Arm B: Bortezomib + Dexamethasone

Arm Description

On days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) will be administered other days Dexamethasone 20 mg Oral will be administered

Outcomes

Primary Outcome Measures

Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants

PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.

Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants

PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.

1 Year Progression-Free Survival Rate - Randomized Participants

PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.

Secondary Outcome Measures

Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele

PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.

Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants

ORR was calculated for participants with a best overall response (BOR) of partial response (PR) or better, including stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage.

Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele

ORR was calculated for participants with a BOR of PR or better, sCR, CR, and VGPR. BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.

Full Information

NCT ID

NCT01478048

First Posted

November 2, 2011

Last Updated

April 20, 2018

Sponsor

Bristol-Myers Squibb

Collaborators

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT01478048

Brief Title

Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Official Title

A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

November 30, 2011 (Actual)

Primary Completion Date

May 30, 2014 (Actual)

Study Completion Date

April 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Relapsed/Refractory Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

185 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Elotuzumab + Bortezomib + Dexamethasone

Arm Type

Experimental

Arm Description

On days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) will be administered other days Dexamethasone 20 mg Oral will be administered

Arm Title

Arm B: Bortezomib + Dexamethasone

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Elotuzumab

Other Intervention Name(s)

BMS-901608

Intervention Description

Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until subject meets criteria for discontinuation of study drug

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

Velcade®

Intervention Description

Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron®, Intensol®, Dexpak®, Taperpak®

Intervention Description

Tablets; Oral; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron®, Intensol®, Dexpak®, Taperpak®

Intervention Description

Tablets; Oral; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until subject meets criteria for discontinuation of study drug

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron®, Intensol®, Dexpak®, Taperpak®

Intervention Description

Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until subject meets criteria for discontinuation of study drug

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron®, Intensol®, Dexpak®, Taperpak®

Intervention Description

Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug

Primary Outcome Measure Information:

Title

Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants

Description

Time Frame

Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years

Title

Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants

Description

Time Frame

Randomization until 111 events, up to May 2014, approximately 2 years

Title

1 Year Progression-Free Survival Rate - Randomized Participants

Description

Time Frame

Year 1 after last participant was randomized

Secondary Outcome Measure Information:

Title

Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele

Description

Time Frame

Randomization until 111 events, up to May 2014, approximately 2 years

Title

Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants

Description

Time Frame

Randomization until 111 events, up to May 2014, approximately 2 years

Title

Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele

Description

Time Frame

Randomization until 111 events, up to May 2014, approximately 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. Inclusion Criteria: Documented progression from most recent line of therapy Measurable disease 1 to 3 prior lines of therapy Subjects may be proteasome inhibitor naive or have received prior proteasome inhibitor therapy provided all the following criteria are met: The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI) Exclusion Criteria: Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or Waldenstrom's macroglobulinemia Active plasma cell leukemia Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Compassionate Cancer Res Grp

City

Corona

State/Province

California

ZIP/Postal Code

92879

Country

United States

Facility Name

Local Institution

City

Corona

State/Province

California

ZIP/Postal Code

92879

Country

United States

Facility Name

Local Institution

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

USC Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Ucla Department Of Medicine

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Medical Oncology Care Associates

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Sharp Clinical Oncology Research

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Kaiser Permanente Medical Center

City

Vallejo

State/Province

California

ZIP/Postal Code

94589

Country

United States

Facility Name

Local Institution

City

Vallejo

State/Province

California

ZIP/Postal Code

94589

Country

United States

Facility Name

Cancer Specialists of North FL

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Mount Sinai Comprehensive Cancer Center

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Palm Beach Cancer Institute

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Kaiser Permanente-Moanalua Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96819

Country

United States

Facility Name

University Of Chicago Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Local Institution

City

Decatur

State/Province

Illinois

ZIP/Postal Code

62526

Country

United States

Facility Name

Oncology Specialists, S.C.

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

Local Institution

City

Urbana

State/Province

Illinois

ZIP/Postal Code

61801

Country

United States

Facility Name

Investigative Clinical Research Of Indiana, Llc

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Local Institution

City

Hazard

State/Province

Kentucky

ZIP/Postal Code

41701

Country

United States

Facility Name

University Of Kentucky Markey Cancer Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Pikeville Medical Center Leonard Lawson Cancer Center

City

Pikeville

State/Province

Kentucky

ZIP/Postal Code

41501

Country

United States

Facility Name

Cancer Center Of Acadiana

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70503

Country

United States

Facility Name

Local Institution

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Local Institution

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01608

Country

United States

Facility Name

Henry Ford Health System

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Washington University School Of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Mercy Medical Research Institute

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Southern Nevada Cancer Research Foundation

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Waverly Hematology Oncology

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

St. Agnes Hospital

City

Baltimore

State/Province

Pennsylvania

ZIP/Postal Code

21229

Country

United States

Facility Name

Cancer Care Associates

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Penn State Hershey Cancer Institute

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Penn State Hershey Cancer Inst

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

The Western Pennsylvania Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Medical University Of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Local Institution

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Charles A. Sammons Cancer Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Northwest Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Local Institution

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Local Institution

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Name

Local Institution

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Local Institution

City

Grenoble Cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

Local Institution

City

Le Mans

ZIP/Postal Code

72037

Country

France

Facility Name

Local Institution

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Local Institution

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Local Institution

City

Paris 12

ZIP/Postal Code

75012

Country

France

Facility Name

Local Institution

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Local Institution

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54500

Country

France

Facility Name

Local Institution

City

Milano

State/Province

Parma

ZIP/Postal Code

20132

Country

Italy

Facility Name

Local Institution

City

Roma

State/Province

Parma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Local Institution

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

Local Institution

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Local Institution

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Local Institution

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Local Institution

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Local Institution

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Local Institution

City

Lecce

ZIP/Postal Code

73100

Country

Italy

Facility Name

Local Institution

City

Meldola (fc)

ZIP/Postal Code

47014

Country

Italy

Facility Name

Local Institution

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Local Institution

City

Pescara

ZIP/Postal Code

65124

Country

Italy

Facility Name

Local Institution

City

Ravenna

ZIP/Postal Code

48100

Country

Italy

Facility Name

Local Institution

City

Rimini

ZIP/Postal Code

47900

Country

Italy

Facility Name

Local Institution

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Local Institution

City

Roma

ZIP/Postal Code

161

Country

Italy

Facility Name

Local Institution

City

Rome

ZIP/Postal Code

00144

Country

Italy

Facility Name

Local Institution

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Local Institution

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Facility Name

Local Institution

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Local Institution

City

Santiago Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Local Institution

City

Toledo

ZIP/Postal Code

45004

Country

Spain

Facility Name

Local Institution

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Local Institution

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Local Institution

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

27091875

Citation

Jakubowiak A, Offidani M, Pegourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, Palumbo A. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016 Jun 9;127(23):2833-40. doi: 10.1182/blood-2016-01-694604. Epub 2016 Apr 18.

Results Reference

derived

Links:

URL

http://bms.com/studyconnect/Pages/home.aspx

Description

BMS Clinical Trial Patient Recruiting

Learn more about this trial

Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

We'll reach out to this number within 24 hrs

Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Multiple Myeloma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial