Multiple MyelomaPhase 2NCT03361306
LCI-HEM-MYE-CRD-002: Carfilzomib-Revlimid-Dexamethasone-Elotuzumab in Relapsed/Refractory Multiple Myeloma
A Phase 2 study testing Elotuzumab in people with Multiple Myeloma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The study drug elotuzumab, has been clinically shown to be effective in treating relapsed/refractory MM in combination with either bortezomib, or lenalidomide and dexamethasone. Elotuzumab in combination with lenalidomide and dexamethasone is currently approved by the Food and Drug Administration (FDA) for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Elotuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2018to 14 Feb 2025
- 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
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information signed by the subject or his/her legally authorized representative.
- Age >= 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 (see Appendix A, Section 18.1).
- Documented history of relapsed and/or refractory multiple myeloma per IMWG 2016 criteria [22] as defined below (biochemical and/or clinical relapse per IMWG criteria); (NOTE: subjects refractory to bortezomib and/or lenalidomide are eligible; subjects who previously received carfilzomib are eligible provided they experienced a minimal response or better and relapsed >60 days after completion of treatment [see exclusion criteria #2]):
- Relapse is defined as progression of disease after an initial response to previous treatment, more than 6 months after discontinuation of treatment.
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- Refractory is defined as lack of response to previous treatment, progression of disease during treatment, or progression of disease within 6 months of discontinuation of treatment.
- Prior treatment with one line (and no more than one line) of systemic therapy for MM; NOTE: A new line of therapy is considered to start when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of progressive disease (PD), relapse, or toxicity or when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. Induction therapy and stem cell transplant followed by planned maintenance therapy (provided there is no intervening PD) are considered to be a single line.
- Subject must have recovered from any treatment-induced toxicities to ≤ grade 1 or baseline
- Adequate washout from previous therapy:
- Prior chemotherapy is completed >3 weeks prior to day 1 of treatment (6 weeks for melphalan, nitrosoureas or monoclonal antibodies).
- Autologous transplant completed (referring to day of stem cell infusion) >12 weeks prior to day 1 of treatment; allogeneic transplant >16 weeks prior to day 1 of treatment.
- Prior radiotherapy completed at least 2 weeks prior to day 1 of treatment.
- Corticosteroid therapy at a dose equivalent to dexamethasone >4mg/day has been completed at least 2 weeks prior to day 1 of treatment.
- Measurable disease defined as:
- Serum M-protein > 0.5 g/dL OR
- Urine M-protein ≥200 mg/24 h OR
- Involved free light chain (FLC) level ≥10 mg/dL provided serum FLC ratio is abnormal.
- Demonstrate adequate organ function within 1 week of day 1 of treatment as defined in the table in Sec.tion 3.2 of protocol (#8)
- Adequate cardiac function as defined by ≥45% Left Ventricular Ejection Fraction (LVEF) by ECHO or MUGA within 28 days prior to day 1 of treatment.
- Females of childbearing potential (FCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to day 1 of treatment, and be willing to undergo serial serum or urine pregnancy testing. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause).
- FCBP must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of <1% per year when used consistently and correctly) plus a second contraceptive method (considered acceptable [failure rate of >1% per year] or highly effective) from the time of informed consent until 6 months after the last protocol prescribed therapy has been discontinued. NOTE: estrogens may further increase the risk of thrombosis (beyond that associated with lenalidomide) and their use should be based on a benefit-risk decision. For the highly effective contraceptive method, a method with low user dependency is preferable but not required (see tables, adapted from:
- http://www.hma.eu/fileadmin/dateien/HumanMedicines/01-AboutHMA/WorkingGroups/CTFG/201409HMACTFGContraception.pdf).
- Male subjects (even those who have had a vasectomy) who are sexually active with a FCBP must be willing to use latex or synthetic condoms from the time of informed consent until 180 days after the last protocol prescribed therapy has been discontinued. The FCBP partner should also consider contraception recommendations (see inclusion #11).
- As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study.
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Discontinuation of previous lenalidomide, carfilzomib or dexamethasone due to intolerance.
- If previously treated with carfilzomib, lack of response, progression during or relapsed within 60 days after completion of treatment.
- Any infection, at the time of screening, requiring systemic therapy (i.e. involving IV antibiotics) (NOTE: at discretion of investigator, subjects with uncomplicated urinary tract infections may be eligible).
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study, and any female subject must agree not to donate eggs during the study and for 4 months after the last protocol prescribed therapy has been discontinued).
- Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, carcinoma of the prostate with a current PSA value of <0.5 ng/mL or other cancer for which the subject has completed treatment, been disease-free for at least five years, and is considered by Sponsor-Investigator to be at <30% risk of relapse, or on hormonal therapy for a history of either prostate cancer or breast cancer, provided that there has been no evidence of disease progression during the previous three years.
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- Non-secretory MM.
- Active involvement of the central nervous system by MM.
- Prior cardiovascular cerebrovascular accident with persistent neurological deficit.
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Had major surgery within 4 weeks prior to day 1 of treatment.
- Plasmapheresis within 4 weeks from day 1 of treatment.
- Treatment with any investigational drug within 4 weeks prior to day 1 of treatment.
- Uncontrolled clinically significant illness including, but not limited to, uncontrolled hypertension (as per the most updated Joint National Committee for the Management of Hypertension definitions), symptomatic congestive heart failure (as per New York Heart Association [NYHA] class III or IV [see Appendix C, Section 18.3], uncontrolled angina pectoris, myocardial infarction within the past 6 months, known or suspected amyloidosis, uncontrolled cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator, or any other condition (including laboratory abnormalities) that would, in the opinion of the Sponsor-Investigator, place the subject at unacceptable risk if he/she were to participate in the study.
- Known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, elotuzumab or its excipients or known sensitivity to mammalian-derived products, carfilzomib or its excipients, lenalidomide or its excipients, or dexamethasone or its excipients.
- Known human immunodeficiency virus (HIV) infection or active hepatitis A, B and/or C infection.
- Subjects with resolved HBV infection (i.e. subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Subjects who are PCR positive will be excluded. Exception: subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
Official title: LCI-HEM-MYE-CRD-002: A Phase II Study of Carfilzomib- Revlimid-Dexamethasone-Elotuzumab in Relapsed/Refractory Multiple Myeloma
The study drug elotuzumab, has been clinically shown to be effective in treating relapsed/refractory MM in combination with either bortezomib, or lenalidomide and dexamethasone. Elotuzumab in combination with lenalidomide and dexamethasone is currently approved by the Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma. Carfilzomib is also FDA approved for treating multiple myeloma and frequently given in combination with lenalidomide and dexamethasone for treatment of relapsed/refractory MM. Based on these findings, this study will look at how subjects with relapsed/refractory MM respond to a combination treatment with the following drugs: elotuzumab, carfilzomib, lenalidomide and dexamethasone. The combination of these four drugs is not FDA approved and is experimental.
Read the detailed description
This single arm, open-label phase II study is designed with the primary objective of evaluating the efficacy of induction therapy comprised of 4 cycles of carfilzomib, lenalidomide, dexamethasone and elotuzumab (KRd+elotuzumab) in terms of very good partial response or better (VGPR+) in subjects with relapsed and/or refractory MM, and comparing to relevant historical controls. Post induction, all subjects will undergo disease evaluation for assessment of the primary endpoint. Maintenance therapy comprised of elotuzumab and lenalidomide (R+elotuzumab) will start directly after induction and continue until relapse or progression.
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab
- Keywords
- Relapsed
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElotuzumabDrug
Also called Empliciti
Experimental
| Study group | Role | What they receive |
|---|---|---|
| KRd-Elotuzumab | Experimental | Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m^2, Day 1 of Cycle 1; @ 56 mg/m^2, Day 8,15 of Cycle 1; @ 56 mg/m^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if <15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n) Receives: Drug: Elotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With VGPR or Better Response to Induction
The primary endpoint is a binary variable determined for each subject indicating whether the subject achieved a very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) to induction treatment with KRd-Elo, as defined by the IMWG 2016 response criteria. Per IMWG 2016 criteria, VGPR is defined as serum/urine M-protein detectable by immunofixation but not electrophoresis OR >= 90% reduction in serum M protein plus urine M-protein <100 mg/24 h. CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
Measured: From enrollment to the disease response determined at the end of the induction part of regimen (4 cycles of KRd-Elo was planned, but some subjects progressed before the end of induction). The median length of induction was 16 weeks.
Secondary outcomes (6)
Number of Subjects With an Objective Response
Objective response was determined for each subject as a binary variable indicating whether the subject achieved a best overall response of partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) at any time on study treatment as determined by IMWG 2016 response criteria. Per IMWG 2016 criteria, PR is defined as at least 50% reduction of serum M-protein plus reduction in 24 hour urinary M-protein by 90% or to <200 mg/24h. VGPR is defined as serum/urine M-protein detectable by immunofixation but not electrophoresis OR >= 90% reduction in serum M protein plus urine M-protein <100 mg/24 h. CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
Measured: From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity. Subjects were on treatment for a median of 12 months.
Overall Survival (OS)
OS is defined as the duration from treatment start date to the date of death from any cause. Subjects who are alive or lost to follow up at the time of the analysis will be censored at the last known date they were alive.
Measured: From date of treatment start to date of death, or censored as described; assessed for approximately 5 years.
Progression Free Survival (PFS)
PFS is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death. PD must be objectively determined per IMWG 2016 criteria, where progression date is date of last assessment that identified PD. If subject died without documented PD, progression date will be death date. For surviving subjects who do not have PD, PFS will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.
Measured: From treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.
Time to Disease Progression (TTP)
TTP is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death related to disease progression. PD must be objectively determined per IMWG 2016 criteria, where progression date is date of last assessment that identified PD. If a subject died for causes related to disease progression then progression date will be date of death. If a subject died for causes other than disease progression, TTP will be censored at the date of other cause mortality. For surviving subjects who do not have PD, TTP will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, TTP will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial TTP event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.
Measured: From treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.
Duration of Response (DoR)
DoR will be calculated for each subject with a partial response, very good partial response, complete response, or stringent complete response on study treatment. The DoR intervals will be calculated from the time of the first assessment that identified response until disease progression or death. The censoring mechanism for DoR will be the same as described for PFS.
Measured: From time of first response to date of progression/death, or censored as described; assessed for approximately 3 years.
Time to Next Treatment (TTNT)
TTNT will be calculated from the time of treatment start until the start of the first subsequent anti-cancer therapy after all protocol directed therapy is completed. For surviving subjects who do not receiving subsequent therapy, TTNT will be censored at the last contact date. For subjects who die before beginning subsequent anti-cancer therapy, TTNT will be censored at the date of death
Measured: From treatment start date to date of next treatment, or censored as described; assessed for approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start9 Jan 2018
- Primary completion4 Jun 2021
- Study completion14 Feb 2025
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 Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Manisha Bhutani, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361306
- Sponsor's protocol ID
- LCI-HEM-MYE-CRD-002
- Other IDs
- 00023493
- Status last verified
- Feb 2026
- First submitted
- 20 Nov 2017
- Last updated
- 6 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhutani M, Foureau DM, Robinson M, Guo F, Fesenkova K, Atrash S, Paul B, Varga C, Friend R, Pineda-Roman M, Rigby K, Symanowski JT, Norek S, Tucker MR, Druhan LJ, Voorhees PM, Usmani SZ. A Clinical and Correlative Study of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd) for Lenalidomide Refractory Multiple Myeloma in First Relapse. Clin Lymphoma Myeloma Leuk. 2023 Jul;23(7):535-544.e1. doi: 10.1016/j.clml.2023.03.016. Epub 2023 Apr 7.
PubMed 37127471
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCI-HEM-MYE-CRD-002: A Phase II Study of Carfilzomib- Revlimid-Dexamethasone-Elotuzumab in Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03361306
- Acronym / sponsor ID
- LCI-HEM-MYE-CRD-002
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Atrium Health Levine Cancer Institute
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Posted 26 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study drug elotuzumab, has been clinically shown to be effective in treating relapsed/refractory MM in combination with either bortezomib, or lenalidomide and dexamethasone. Elotuzumab in combination with lenalidomide and dexamethasone is currently approved by the Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma. Carfilzomib is also FDA approved for treating multiple myeloma and frequently given in combination with lenalidomide and dexamethasone for treatment of relapsed/refractory MM. Based on these findings, this study will look at how subjects with relapsed/refractory MM respond to a combination treatment with the following drugs: elotuzumab, carfilzomib, lenalidomide and dexamethasone. The combination of these four drugs is not FDA approved and is experimental.
Detailed description
This single arm, open-label phase II study is designed with the primary objective of evaluating the efficacy of induction therapy comprised of 4 cycles of carfilzomib, lenalidomide, dexamethasone and elotuzumab (KRd+elotuzumab) in terms of very good partial response or better (VGPR+) in subjects with relapsed and/or refractory MM, and comparing to relevant historical controls. Post induction, all subjects will undergo disease evaluation for assessment of the primary endpoint. Maintenance therapy comprised of elotuzumab and lenalidomide (R+elotuzumab) will start directly after induction and continue until relapse or progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KRd-Elotuzumab | Experimental | Drug: ElotuzumabInduction (4 28-day cycles): Carfilzomib (IV) @ 20 mg/m^2, Day 1 of Cycle 1; @ 56 mg/m^2, Day 8,15 of Cycle 1; @ 56 mg/m^2, Day 1,8,15 of Cycles 2-4 Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4) Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4 Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4 Maintenance (28-day cycles): Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n) Lenalidomide (Oral) @ 15 mg (or last tolerated dose if <15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information signed by the subject or his/her legally authorized representative.
- Age >= 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 (see Appendix A, Section 18.1).
- Documented history of relapsed and/or refractory multiple myeloma per IMWG 2016 criteria [22] as defined below (biochemical and/or clinical relapse per IMWG criteria); (NOTE: subjects refractory to bortezomib and/or lenalidomide are eligible; subjects who previously received carfilzomib are eligible provided they experienced a minimal response or better and relapsed >60 days after completion of treatment [see exclusion criteria #2]):
Key exclusion criteria (17 listed)
- Discontinuation of previous lenalidomide, carfilzomib or dexamethasone due to intolerance.
- If previously treated with carfilzomib, lack of response, progression during or relapsed within 60 days after completion of treatment.
- Any infection, at the time of screening, requiring systemic therapy (i.e. involving IV antibiotics) (NOTE: at discretion of investigator, subjects with uncomplicated urinary tract infections may be eligible).
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study, and any female subject must agree not to donate eggs during the study and for 4 months after the last protocol prescribed therapy has been discontinued).
- Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, carcinoma of the prostate with a current PSA value of <0.5 ng/mL or other cancer for which the subject has completed treatment, been disease-free for at least five years, and is considered by Sponsor-Investigator to be at <30% risk of relapse, or on hormonal therapy for a history of either prostate cancer or breast cancer, provided that there has been no evidence of disease progression during the previous three years.
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: EmplicitiExperimental | Drug | KRd-Elotuzumab |
Primary outcome
Number of Participants With VGPR or Better Response to Induction
Time frame: From enrollment to the disease response determined at the end of the induction part of regimen (4 cycles of KRd-Elo was planned, but some subjects progressed before the end of induction). The median length of induction was 16 weeks.
The primary endpoint is a binary variable determined for each subject indicating whether the subject achieved a very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) to induction treatment with KRd-Elo, as defined by the IMWG 2016 response criteria. Per IMWG 2016 criteria, VGPR is defined as serum/urine M-protein detectable by immunofixation but not electrophoresis OR >= 90% reduction in serum M protein plus urine M-protein <100 mg/24 h. CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
6 secondary outcomes
Number of Subjects With an Objective Response
Time frame: From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity. Subjects were on treatment for a median of 12 months.
Overall Survival (OS)
Time frame: From date of treatment start to date of death, or censored as described; assessed for approximately 5 years.
Progression Free Survival (PFS)
Time frame: From treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.
Time to Disease Progression (TTP)
Time frame: From treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.
Duration of Response (DoR)
Time frame: From time of first response to date of progression/death, or censored as described; assessed for approximately 3 years.
Time to Next Treatment (TTNT)
Time frame: From treatment start date to date of next treatment, or censored as described; assessed for approximately 3 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37127471Bhutani M, Foureau DM, Robinson M, Guo F, Fesenkova K, Atrash S, Paul B, Varga C, Friend R, Pineda-Roman M, Rigby K, Symanowski JT, Norek S, Tucker MR, Druhan LJ, Voorhees PM, Usmani SZ. A Clinical and Correlative Study of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd) for Lenalidomide Refractory Multiple Myeloma in First Relapse. Clin Lymphoma Myeloma Leuk. 2023 Jul;23(7):535-544.e1. doi: 10.1016/j.clml.2023.03.016. Epub 2023 Apr 7.
- Individual participant dataSharing planned: No
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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.
Manisha Bhutani, MD principal investigator
Wake Forest University Health Sciences
1 site 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 in people with Multiple Myeloma, run by Wake Forest University Health Sciences at 1 site 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 25 inclusion and 17 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 26 Jul 2022). 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?
Number of Participants With VGPR or Better Response to Induction (time frame: From enrollment to the disease response determined at the end of the induction part of regimen (4 cycles of KRd-Elo was planned, but some subjects progressed before the end of induction). The median length of induction was 16 weeks.). 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 NCT03361306, 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 6 Mar 2026.