E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02279394 |
Recruitment Status :
Active, not recruiting
First Posted : October 31, 2014
Last Update Posted : November 3, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoldering Myeloma Smoldering Multiple Myeloma | Drug: Elotuzumab Drug: Lenalidomide Drug: Dexamethasone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | E- PRISM: Precision Intervention Smoldering Myeloma: Phase II Trial of Combination of Elotuzumab, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma |
Actual Study Start Date : | December 11, 2014 |
Actual Primary Completion Date : | September 3, 2021 |
Estimated Study Completion Date : | October 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Elo / Len / Dex
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 & 15 Cycles 3-8 Other Name: HuLuc63 •Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24 Other Name: REVLIMID •Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8 Other Name: Decadron |
Drug: Elotuzumab
10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 & 15 Cycles 3-8
Other Name: HuLuc63 Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
Other Name: Decadron |
Experimental: Elo / Len
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 & 15 Cycles 3-8 Other Name: HuLuc63 •Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24 Other Name: REVLIMID |
Drug: Elotuzumab
10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 & 15 Cycles 3-8
Other Name: HuLuc63 Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID |
- Proportion of patients who are progression free at 2 years [ Time Frame: 2 Years ]Time from protocol therapy initiation to progression to symptomatic myeloma
- Response rate [ Time Frame: 2 Years ]Response rate based on the IMWG criteria
- Safety of the combination therapy [ Time Frame: 4 years ]safety of the combination of Elotuzumab, lenalidomide+/- dexamethasone
- Time to progression [ Time Frame: 4 years ]Time from initiation of therapy to progression defined by the IMWG criteria.
- Overall survival [ Time Frame: 2 Years ]Time from initiation of therapy to death

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years
- Must have smoldering myeloma with high risk markers based on the Mayo OR the Spanish criteria as described below
-
>10% plasma cells in the bone marrow and any one or more of the following:
- Serum M protein of 3 g/dL or greater
- IgA SMM
- Immunoparesis with reduction of two uninvolved immunoglobulin isotypes
- Serum involved/uninvolved free light chain ratio ≥8 (but less than 100)
- Progressive increase in M protein level (Evolving type of SMM)†
- Bone marrow clonal plasma cells 50-60%
- Abnormal plasma cell immunophenotype (≥95% of bone marrow plasma cells are clonal) and reduction of one or more uninvolved immunoglobulin isotypes
- t (4;14) or del 17p or 1q gain
- Increased circulating plasma cells
- MRI with diffuse abnormalities or 1 focal lesion
- PET-CT with focal lesion with increased uptake without underlying osteolytic bone destruction † Increase in serum monoclonal protein by ≥25% on two successive evaluations within a 6 month period
-
No evidence of CRAB (see below for details) criteria or new criteria of active multiple myeloma which including the following:
- Increased calcium levels (corrected serum calcium >0.25 mmol/dL above the upper limit of normal or >.275 mmol/dL)
- Renal insufficiency (attributable to myeloma)
- Anemia (Hb 2g/dL below the lower limit of normal or <10g/dL)
- Bone lesions (lytic lesions or generalized osteoporosis with compression fractures)
-
No evidence of the following new criteria for active MM including the following: Bone marrow plasma cells ≥ 60%, Serum involved/uninvolved FLC ratio ≥100, and MRI with more than one focal lesion
- Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible
- ECOG Performance Status (PS) 0, 1, or 2 (Appendix A)
-
The following laboratory values obtained ≤ 14 days prior to registration:
- ANC ≥1000/µL
- PLT ≥ 50,000/µL
- Total bilirubin ≤ 2.0 mg/dL (If total is elevated check direct and if normal patient is eligible.)
- AST ≤ 3 x institutional upper limit of normal (ULN)
- ALT ≤ 3 x institutional upper limit of normal (ULN)
- Estimated creatinine clearance ≥ 60mL/min or a creatinine ≤ 2.2 mg/dL
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Females of childbearing potential* must have a negative serum or urine pregnancy test
- Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy
- Ability to understand and the willingness to sign a written informed consent.
- Exclusion Criteria:
- Symptomatic Multiple Myeloma or any evidence of CRAB criteria including the new criteria for overt myeloma. Any prior therapy for active Myeloma should also be excluded. Prior therapy for smoldering myeloma is not an exclusion criteria. Bisphosphonates are not excluded
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. Prior therapy with bisphosphonate is allowed. Prior radiation therapy to a solitary plasmacytoma is allowed. Prior clinical trials for smoldering MM or MGUS are allowed as long as the last therapy was at least 2 months prior and there was no improvement in M spike
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
- Uncontrolled intercurrent illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to elotuzumab or lenalidomide
- Known seropositive for or active viral infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus. Patients who are seropositive because of hepatitis B virus vaccine are eligible

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279394
United States, Colorado | |
Colorado Blood Cancer Institute | |
Denver, Colorado, United States, 80218 | |
United States, Connecticut | |
St Francis Hospital and Medical Center | |
Hartford, Connecticut, United States, 06105 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Maine | |
Eastern Maine Medical Center | |
Brewer, Maine, United States, 04412 | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 | |
United States, North Carolina | |
Levine Cancer Institute | |
Charlotte, North Carolina, United States, 28204 |
Principal Investigator: | Irene Ghobrial, MD | Dana-Farber Cancer Institute |
Responsible Party: | Irene Ghobrial, MD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT02279394 |
Other Study ID Numbers: |
14-338 |
First Posted: | October 31, 2014 Key Record Dates |
Last Update Posted: | November 3, 2021 |
Last Verified: | November 2021 |
Smoldering myeloma Smoldering Multiple Myeloma |
Multiple Myeloma Neoplasms, Plasma Cell Smoldering Multiple Myeloma Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Precancerous Conditions Hypergammaglobulinemia Dexamethasone Lenalidomide Elotuzumab Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |