Clinical Trials Logo
  1. Home
  2. Multiple Myeloma
  3. NCT02159365
  4. Details
NCT02159365 Clinical Trial

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

Multiple Myeloma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02159365
Other study ID # CA204-112
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 8, 2014
Est. completion date July 11, 2018

Study information
Verified date July 2019
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date July 11, 2018
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Elotuzumab

• Lenalidomide

• Dexamethasone

Locations
Country Name City State
United States Comprehensive Blood And Cancer Center Bakersfield California
United States Blue Ridge Cancer Care Blacksburg Virginia
United States Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Texas Oncology Dallas Texas
United States Rocky Mountain Cancer Centers Llp Denver Colorado
United States California Cancer Associates for Research and Excellence Encinitas California
United States Highland Oncology Group Fayetteville Arkansas
United States Compassionate Cancer Res Grp Fountain Valley California
United States Robert A. Moss, Md Facp, Inc. Fountain Valley California
United States Greenville Health System Greenville South Carolina
United States St Francis Hospital Greenville South Carolina
United States Local Institution Houston Texas
United States Investigative Clinical Research Of Indiana, Llc Indianapolis Indiana
United States Cancer Specialists Of North Florida Jacksonville Florida
United States Horizon Oncology Research, Inc Lafayette Indiana
United States Center For Cancer Care & Research Lakeland Florida
United States Loma Linda University Cancer Center Loma Linda California
United States Baptist Health Medical Group Oncology Miami Florida
United States Pacific Cancer Care Monterey California
United States Clinical Research Alliance, Inc. New York New York
United States Vista Oncology Inc., PS Olympia Washington
United States Ventura County Hematology-Oncology Specialists Oxnard California
United States Oncology Specialists,S.C Park Ridge Illinois
United States Cancer Centers of South Texas San Antonio Texas
United States Acrc/Arizona Clinical Research Center, Inc. Tucson Arizona
United States Blood & Cancer Center of East Texas Tyler Texas
United States Texas Oncology-McAllen South Second Street Weslaco Texas
United States Wellness Oncology & Hematology West Hills California
United States James R. Berenson, MD, Inc. West Hollywood California

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2 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. From Day 1 to End of cycle 2 treatment (approximately 56 days)
Secondary Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period 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. Date of first dose up to 60 days post last dose (approximately 4 years)
See also
  Status Clinical Trial Phase
Recruiting NCT05027594 - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02412878 - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma Phase 3
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT03570983 - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1

External Links