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
| Verified date | July 2019 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| 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) |
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