Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Primary Hyperoxaluria Type 3

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Anti-Infective Agents

Dexamethasone

Lenalidomide

Dexamethasone acetate

BB 1101

Elotuzumab

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug

Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug

Lenalidomide 25 mg capsules by mouth once daily (Days 1-21)

Dexamethasone 28 mg tablets by mouth once daily \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15(cycles 3-18); Day 1 (cycle 19 \& beyond)\]

Dexamethasone 40 mg tablets by mouth once daily \[Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 \& beyond)\]

Dexamethasone 8 mg IV (intravenous) solution once daily \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15 (cycles 3-18); Day 1 (cycle 19 \& beyond)\]

Elotuzumab 10 mg/kg IV solution weekly \[Days 1, 8, 15, 22 (cycles 1 \& 2); Days 1 \& 15 (cycles 3-18)\]

Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 \& beyond)

Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug

Bristol-Myers Squibb

The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab

PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at baseline and at time of progression through mean fluorescent intensity.

The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM)

CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at time of progression.

The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM)

Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection

Circulating MM cells isolated from peripheral blood

CS1 expression levels analyzed from matching bone marrow aspirates (for bone marrow-derived MM cells) and from peripheral blood (for circulating tumor cells) collected from the same participants

Abbott

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

E-Ld Cohort

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Ld Cohort

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Bristol-Myers Squibb Study Director

All treated participants with measurements available at baseline and at time of progression.

No participants in any of the 2 cohorts had available measurements both at baseline and time of progression

Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells

All treated participants with measurements available at time of progression.

Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression

Baseline

Cycle 3 day 1 of main study therapy

Time of progression

All treated participants with measurements available either at baseline, at cycle 3 day 1 of study therapy or at time of progression.

Levels of CS1 Soluble Form (sCS1) in Serum

From baseline to Cycle 3 day 1 of main study therapy

From baseline to time of progression

All treated participants with measurements available at baseline and at cycle 3 day 1 of study therapy or at baseline and at the time of progression.

Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression

From baseline to Cycle 3 day 1 of study therapy

All treated participants with available circulating MM cells. Circulating MM cells were not collected for any of the participants.

Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells

All treated participants with available circulating MM cells and CS1 expression levels.

Circulating MM cells were not collected for any of the participants.

Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells

All treated participants with matched samples of bone marrow-derived MM cells and circulating MM cells.

Circulating MM cells were not collected for any of the participants.

Spots Global Cancer Trial Database for PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial