Multiple Myeloma in RelapsePhase 2KEdNCT03155100
Carfilzomib + Elotuzumab + Dexamethasone for Relapsed Multiple Myeloma After 1-3 Prior Treatment Lines
A Phase 2 study testing Carfilzomib for Inj 60 milligram (MG), Elotuzumab 400 MG and Dexamethasone in people with Multiple Myeloma in Relapse, run by Raija Silvennoinen at 8 sites in 2 countries.
Trial summary
The main aim of this study is to assess the ORR with a new drug combination, carfilzomib (CAR) + elotuzumab (ELO) + dexamethasone (CAR-ELO-Dex). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Multiple Myeloma in Relapse
- What is being tested?
- Carfilzomib for Inj 60 milligram (MG), Elotuzumab 400 MG and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 7 Aug 2017to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients at the age of 18 to below 75 years with the life expectancy of at least three months.
- Prior confirmed diagnosis of multiple myeloma and measurable disease in blood or urine with at least one of the following: Serum M-protein ≥ 5g/l, Urine M-protein ≥ 200 mg/24 hours, In subjects without detectable serum or urine M-component, serum free light chain (S-FLC) > 100 ml/l (involved light chain) and an abnormal serum kappa/lambda ratio
- Relapse or progression after 1 to 3 prior treatment lines, which have included proteasome inhibitors (bortezomib, carfilzomib and/or ixazomib) and/or lenalidomide. Refractoriness to bortezomib, ixazomib and/or lenalidomide is allowed in the preceding cycle. Patients with previous autologous transplantation can be included.
- Need of treatment of relapse or progression: IMWG criteria for relapse/progression (paraprotein or hypercalcemia, renal insufficiency, anemia, bone disease (CRAB) criteria or both). (Appendix 5)
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.
- Females of childbearing potential (FCBP) must have a confirmed negative serum pregnancy test within the 7 days prior to inclusion
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- Females of childbearing potential must use one effective method of contraception and their partners condom during the study and for 120 days following the last study drug treatment dose and male subjects who are sexually active with FCBP must agree to use condom during the study and for 180 days following the last study drug treatment dose.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2, or Karnofsky at least 60.
- Patients must meet the following adequate organ and bone marrow function within 21 days prior to inclusion:
- Absolute neutrophil count (ANC) 1,000/mm3 (≥ 1.0 x 109/L) and platelet count 75 x 109/L. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment. Granulocyte growth factors are allowed to meet the inclusion criteria.
- Hemoglobin (Hb) ≥ 80 g/l (use of erythropoietin and red blood cell transfusions allowed by institutional guidelines, however the most recent red blood cells (RBC) may not have given within 7 days prior to obtaining screening Hb
- Total bilirubin < 1.5 times the upper limit of the normal range (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 times the ULN.
- Calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault estimation of creatinine clearance (CRcl): CRcl (mL/min) = (140 - age) x (weight [kg]) / 72 x (serum creatinine [mg/dL]); for females, multiply by 0.85 (Cockcroft 1976, Luke 1990)
- Patient must be willing and able to adhere to the study protocol visit schedule and other protocol requirements.
- Negative pregnancy test at inclusion if applicable
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Major surgery within 28 days before enrollment.
- Radiotherapy within 14 days before enrollment, but if the involved field is small, 7 days will be considered a sufficient interval before onset of the treatment.
- Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
- Central nervous system involvement.
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- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.
- Active congestive heart failure (NYHA III-IV) (Appendix 3), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment or left ventricular ejection fraction (LVEF) <40% within one month before randomization.
- Ongoing or active systemic infection, active hepatitis A, B or C virus infection, or known human immunodeficiency virus (HIV) positivity.
- Any other serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Known allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib) or to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Contraindication to dexamethasone or any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
- Diagnosed or treated for another malignancy within 5 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Patient has ≥ Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination within the 14 days prior to inclusion.
- Participation in another interventional study within the 28 days before this study inclusion.
- Patients refractory to carfilzomib or elotuzumab.
- Primary plasma cell leukemia, systemic AL amyloidosis, Waldenström macroglobulinemia, rare Immunoglobulin M (IgM) multiple myeloma, POEMS syndrome, myelodysplasia
- Allogeneic or autologous stem cell transplantation planned
- Participants receiving any other investigational agents or received within 60 days
- Pleural effusions requiring thoracocentesis within the 14 days prior the inclusion.
- Ascites requiring puncture within the 14 days prior to inclusion.
- Previous allogeneic transplantation
- Uncontrolled hypertension or uncontrolled diabetes despite medication
- Known hepatic cirrhosis
- Severe autoimmune disease
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Finland7 sites
Helsinki University Central Hospital
Helsinki
Central Finland Central Hospital
Jyväskylä
Kymenlaakso Central Hospital
Kotka
Kuopio University Hospital
Kuopio
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
Turku University Hospital
Turku
About this study
Official title: Phase 2 Study of Carfilzomib + Elotuzumab + Dexamethasone for Relapsed or Progressed Multiple Myeloma After 1-3 Prior Treatment Lines
The main aim of this study is to assess the ORR with a new drug combination, carfilzomib (CAR) + elotuzumab (ELO) + dexamethasone (CAR-ELO-Dex).
Read the detailed description
This Nordic Myeloma Study Group study is a phase 2 study for advanced multiple myeloma (MM) patients below 75 years of age. The main aim of this study is to assess the overall response rate (ORR) with a new drug combination, carfilzomib + elotuzumab + dexamethasone (CAR-ELO-Dex). Even if this is not a randomized study rough comparisons can be done with earlier reports of different regimens in the same clinical situation. In addition, safety assessment is of critical importance for a new regimen. A modern concept is to study the depth of complete responses (CR) with a sensitive multiparameter flow cytometry (MFC) method for minimal residual disease (MRD) assessment - an endpoint that is mostly lacking in previous studies for this patient population. We assume that treatment with this new combination of CAR + ELO + Dex will produce at least as good responses as the most efficient regimens so far used in this clinical situation, and there will be a substantial proportion of CR responses with MRD-negativity which can be regarded as an indicator of high-level treatment efficacy and which gives a good basis for comparisons of treatment efficacy between different study regimens in future.
The target population of the study is the patients who have relapsed or progressed after 1 to 3 prior treatment lines in which PI (bortezomib and/or ixazomib) and/or lenalidomide have been included. The primary endpoint is overall response rate while the secondary endpoints include complete remission, duration of response, assessment of the depth (quality) of CR with MRD measurement by flow cytometry, estimation of progression free survival (PFS) and time to next treatment, and evaluation of adverse events and safety.
- Conditions
- Multiple Myeloma in Relapse
- Being tested
- Carfilzomib for Inj 60 milligram (MG), Elotuzumab 400 MG, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carfilzomib for Inj 60 milligram (MG)Drug
Also called Proteasome inhibitor
All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
Elotuzumab 400 MGDrug
Also called Monoclonal antibody
All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
DexamethasoneDrug
Also called Steroid
All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Carfilzomib, elotuzumab, dexamethasone | Experimental | Carfilzomib 70 milligram(mg)/m2 iv (56 mg/m2 for first five patients for cycles 1-2) once weekly, on days 1, 8 and 15 (cycles 1-8), from cycle 9 on days 1 and 15 until progression or toxicity; elotuzumab 10 mg/kg iv on days 1,8,15 for cycles 1-2, on days 1and 15 from cycle 3 until progression or toxicity; dexamethasone 40 mg weekly (shared to po and iv) Receives: Drug: Carfilzomib for Inj 60 milligram (MG); Drug: Elotuzumab 400 MG; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
The proportion of patients having achieved at least partial response.
Measured: 3 years
Secondary outcomes (1)
Severe adverse events
Non-hematological grade 3 or more severe adverse events more or at least 70 percent
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start7 Aug 2017
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- 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
- Raija Silvennoinen
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Bristol-Myers Squibb, Hospital District of Helsinki and Uusimaa
- Responsible party
- Sponsor-investigator, Raija Silvennoinen, Helsinki University Central Hospital
- Investigators
- Raija Silvennoinen, MD, PhD, Principal investigator, Helsinki University Central Hospital CCC Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155100
- Sponsor's protocol ID
- NMSG#24/15
- Other IDs
- 2016-001178-13, 2016
- Acronym
- KEd
- Status last verified
- Sep 2023
- First submitted
- 14 May 2017
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Carfilzomib + Elotuzumab + Dexamethasone for Relapsed or Progressed Multiple Myeloma After 1-3 Prior Treatment Lines
- ClinicalTrials.gov ID
- NCT03155100
- Acronym / sponsor ID
- KEd / NMSG#24/15
- Conditions
- Multiple Myeloma in Relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Raija SilvennoinenUniversity, hospital or other
- Collaborators
- Amgen, Bristol-Myers Squibb, Hospital District of Helsinki and Uusimaa
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to assess the ORR with a new drug combination, carfilzomib (CAR) + elotuzumab (ELO) + dexamethasone (CAR-ELO-Dex).
Detailed description
This Nordic Myeloma Study Group study is a phase 2 study for advanced multiple myeloma (MM) patients below 75 years of age. The main aim of this study is to assess the overall response rate (ORR) with a new drug combination, carfilzomib + elotuzumab + dexamethasone (CAR-ELO-Dex). Even if this is not a randomized study rough comparisons can be done with earlier reports of different regimens in the same clinical situation. In addition, safety assessment is of critical importance for a new regimen. A modern concept is to study the depth of complete responses (CR) with a sensitive multiparameter flow cytometry (MFC) method for minimal residual disease (MRD) assessment - an endpoint that is mostly lacking in previous studies for this patient population. We assume that treatment with this new combination of CAR + ELO + Dex will produce at least as good responses as the most efficient regimens so far used in this clinical situation, and there will be a substantial proportion of CR responses with MRD-negativity which can be regarded as an indicator of high-level treatment efficacy and which gives a good basis for comparisons of treatment efficacy between different study regimens in future.
The target population of the study is the patients who have relapsed or progressed after 1 to 3 prior treatment lines in which PI (bortezomib and/or ixazomib) and/or lenalidomide have been included. The primary endpoint is overall response rate while the secondary endpoints include complete remission, duration of response, assessment of the depth (quality) of CR with MRD measurement by flow cytometry, estimation of progression free survival (PFS) and time to next treatment, and evaluation of adverse events and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carfilzomib, elotuzumab, dexamethasone | Experimental | Drug: Carfilzomib for Inj 60 milligram (MG), Drug: Elotuzumab 400 MG, Drug: DexamethasoneCarfilzomib 70 milligram(mg)/m2 iv (56 mg/m2 for first five patients for cycles 1-2) once weekly, on days 1, 8 and 15 (cycles 1-8), from cycle 9 on days 1 and 15 until progression or toxicity; elotuzumab 10 mg/kg iv on days 1,8,15 for cycles 1-2, on days 1and 15 from cycle 3 until progression or toxicity; dexamethasone 40 mg weekly (shared to po and iv) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female patients at the age of 18 to below 75 years with the life expectancy of at least three months.
- Prior confirmed diagnosis of multiple myeloma and measurable disease in blood or urine with at least one of the following: Serum M-protein ≥ 5g/l, Urine M-protein ≥ 200 mg/24 hours, In subjects without detectable serum or urine M-component, serum free light chain (S-FLC) > 100 ml/l (involved light chain) and an abnormal serum kappa/lambda ratio
- Relapse or progression after 1 to 3 prior treatment lines, which have included proteasome inhibitors (bortezomib, carfilzomib and/or ixazomib) and/or lenalidomide. Refractoriness to bortezomib, ixazomib and/or lenalidomide is allowed in the preceding cycle. Patients with previous autologous transplantation can be included.
- Need of treatment of relapse or progression: IMWG criteria for relapse/progression (paraprotein or hypercalcemia, renal insufficiency, anemia, bone disease (CRAB) criteria or both). (Appendix 5)
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.
Key exclusion criteria (25 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Major surgery within 28 days before enrollment.
- Radiotherapy within 14 days before enrollment, but if the involved field is small, 7 days will be considered a sufficient interval before onset of the treatment.
- Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
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 |
|---|---|---|
| Carfilzomib for Inj 60 milligram (MG)Also: Proteasome inhibitorAll patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone | Drug | Carfilzomib, elotuzumab, dexamethasone |
| Elotuzumab 400 MGAlso: Monoclonal antibodyAll patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone | Drug | Carfilzomib, elotuzumab, dexamethasone |
| DexamethasoneAlso: SteroidAll patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone | Drug | Carfilzomib, elotuzumab, dexamethasone |
Primary outcome
Overall response rate
Time frame: 3 years
The proportion of patients having achieved at least partial response.
1 secondary outcome
Severe adverse events
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- 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.
Raija Silvennoinen, MD, PhD principal investigator
Helsinki University Central Hospital CCC Hematology
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carfilzomib for Inj 60 milligram (MG), Elotuzumab 400 MG and Dexamethasone in people with Multiple Myeloma in Relapse, run by Raija Silvennoinen at 8 sites in 2 countries.
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 16 inclusion and 25 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 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Finland, Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall response rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2023.