Smoldering MyelomaPhase 2NCT02279394
E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma
A Phase 2 study testing Elotuzumab, Lenalidomide and Dexamethasone in people with Smoldering Myeloma and Smoldering Multiple Myeloma, run by Dana-Farber Cancer Institute at 9 sites in United States.
Trial summary
This research study is aimed to determine the proportion of high risk smoldering multiple myeloma patients who are progression free at 2 years after receiving elotuzumab, lenalidomide and dexamethasone combination therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoldering Myeloma, Smoldering Multiple Myeloma
- What is being tested?
- Elotuzumab, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 9 sitesUnited States
- Study dates
- 11 Dec 2014to 26 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 33Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Maryland
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Eastern Maine Medical Center
Brewer, Maine, 04412
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Chicago
Chicago, Illinois, 60637
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
St Francis Hospital and Medical Center
Hartford, Connecticut, 06105
About this study
Official title: E- PRISM: Precision Intervention Smoldering Myeloma: Phase II Trial of Combination of Elotuzumab, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma
This research study is aimed to determine the proportion of high risk smoldering multiple myeloma patients who are progression free at 2 years after receiving elotuzumab, lenalidomide and dexamethasone combination therapy.
Read the detailed description
This research study is a Phase II clinical trial, which tests the effectiveness of the investigational drugs elotuzumab, lenalidomide and dexamethasone in smoldering multiple myeloma. Recent research studies have shown that early treatment of smoldering multiple myeloma may delay or prevent the progression to active multiple myeloma. The purpose of this research study is to learn whether the combination of elotuzumab, lenalidomide and dexamethasone works in treating smoldering multiple myeloma.
- Conditions
- Smoldering Myeloma, Smoldering Multiple Myeloma
- Being tested
- Elotuzumab, Lenalidomide, Dexamethasone
- Keywords
- Smoldering myeloma, Smoldering Multiple Myeloma
- Medical subject headings
- Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElotuzumabDrug
Also called HuLuc63
10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
LenalidomideDrug
Also called REVLIMID
25 mg Oral; Days 1-21 days Cycles 1-24
DexamethasoneDrug
Also called Decadron
40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
| Study group | Role | What they receive |
|---|---|---|
| Elo / Len / Dex | Experimental | •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 Receives: Drug: Elotuzumab; Drug: Lenalidomide; Drug: Dexamethasone |
| Elo / Len | Experimental | •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 Receives: Drug: Elotuzumab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients Who Are Progression Free at 2 Years
Percent of patients who are alive and without documented progression after at least 2-years of follow-up. All patients who receive study treatment are assessed including those who have died or lost to follow-up prior to 2-years. Progression was defined as an increase in SPEP [25% and an absolute increase of 0.5g/d] or UPEP [25% and an absolute increase of 200mg/24hours] on 2 successive evaluations as determined by the IMWG response criteria or documented progression by the FreeLite progressive disease criteria in the absence of serum or urine involvement.
Measured: 2 Years
Secondary outcomes (3)
Objective Response Percent
Percent of patients with objective response defined as partial response or better based on the International Myeloma Working Group Response (IMWG) criteria
Measured: 2 Years from start of treatment
Time to Progression
Time from initiation of therapy to progression defined by the IMWG criteria.
Measured: From start of treatment up to +/- 60 months
Overall Survival
Time from initiation of therapy to death
Measured: From start of treatment up to +/- 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start11 Dec 2014
- Primary completion12 Dec 2018
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoldering MyelomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Celgene, Blood Cancer Research Partnership, Multiple Myeloma Research Consortium, The Leukemia and Lymphoma Society
- Responsible party
- Principal investigator, Irene Ghobrial, MD, Dana-Farber Cancer Institute
- Investigators
- Irene Ghobrial, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279394
- Sponsor's protocol ID
- 14-338
- Status last verified
- May 2023
- First submitted
- 26 Sep 2014
- Last updated
- 9 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kazandjian D, Diamond B, Papadimitriou M, Hill E, Sklavenitis-Pistofidis R, Ziccheddu B, Blaney P, Chojnacka M, Durante M, Maclachlan K, Young R, Usmani S, Davies F, Getz G, Ghobrial I, Korde N, Morgan G, Maura F, Landgren O. Genomic Profiling to Contextualize the Results of Intervention for Smoldering Multiple Myeloma. Clin Cancer Res. 2024 Oct 1;30(19):4482-4490. doi: 10.1158/1078-0432.CCR-24-0210.
PubMed 38652812
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E- PRISM: Precision Intervention Smoldering Myeloma: Phase II Trial of Combination of Elotuzumab, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02279394
- Acronym / sponsor ID
- 14-338
- Conditions
- Smoldering Myeloma, Smoldering Multiple Myeloma
- Keywords
- Smoldering myeloma, Smoldering Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Celgene, Blood Cancer Research Partnership, Multiple Myeloma Research Consortium, The Leukemia and Lymphoma Society
- Study start
- 11 Dec 2014 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 9 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is aimed to determine the proportion of high risk smoldering multiple myeloma patients who are progression free at 2 years after receiving elotuzumab, lenalidomide and dexamethasone combination therapy.
Detailed description
This research study is a Phase II clinical trial, which tests the effectiveness of the investigational drugs elotuzumab, lenalidomide and dexamethasone in smoldering multiple myeloma. Recent research studies have shown that early treatment of smoldering multiple myeloma may delay or prevent the progression to active multiple myeloma. The purpose of this research study is to learn whether the combination of elotuzumab, lenalidomide and dexamethasone works in treating smoldering multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elo / Len / Dex | Experimental | Drug: Elotuzumab, Drug: Lenalidomide, Drug: Dexamethasone•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 |
| Elo / Len | Experimental | Drug: Elotuzumab, Drug: Lenalidomide•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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- 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:
- No evidence of CRAB (see below for details) criteria or new criteria of active multiple myeloma which including the following:
- ECOG Performance Status (PS) 0, 1, or 2 (Appendix A)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElotuzumabAlso: HuLuc6310 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8 | Drug | Elo / Len, Elo / Len / Dex |
| LenalidomideAlso: REVLIMID25 mg Oral; Days 1-21 days Cycles 1-24 | Drug | Elo / Len, Elo / Len / Dex |
| DexamethasoneAlso: Decadron40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8 | Drug | Elo / Len / Dex |
Primary outcome
Percent of Patients Who Are Progression Free at 2 Years
Time frame: 2 Years
Percent of patients who are alive and without documented progression after at least 2-years of follow-up. All patients who receive study treatment are assessed including those who have died or lost to follow-up prior to 2-years. Progression was defined as an increase in SPEP [25% and an absolute increase of 0.5g/d] or UPEP [25% and an absolute increase of 200mg/24hours] on 2 successive evaluations as determined by the IMWG response criteria or documented progression by the FreeLite progressive disease criteria in the absence of serum or urine involvement.
3 secondary outcomes
Objective Response Percent
Time frame: 2 Years from start of treatment
Time to Progression
Time frame: From start of treatment up to +/- 60 months
Overall Survival
Time frame: From start of treatment up to +/- 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38652812Kazandjian D, Diamond B, Papadimitriou M, Hill E, Sklavenitis-Pistofidis R, Ziccheddu B, Blaney P, Chojnacka M, Durante M, Maclachlan K, Young R, Usmani S, Davies F, Getz G, Ghobrial I, Korde N, Morgan G, Maura F, Landgren O. Genomic Profiling to Contextualize the Results of Intervention for Smoldering Multiple Myeloma. Clin Cancer Res. 2024 Oct 1;30(19):4482-4490. doi: 10.1158/1078-0432.CCR-24-0210.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Ghobrial, MD principal investigator
Dana-Farber Cancer Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elotuzumab, Lenalidomide and Dexamethasone in people with Smoldering Myeloma and Smoldering Multiple Myeloma, run by Dana-Farber Cancer Institute at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Patients Who Are Progression Free at 2 Years (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02279394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.