Multiple MyelomaPhase 2NCT03003728
2015-10: Expanded Natural Killer Cells and Elotuzumab for High-Risk Myeloma Post- Autologous Stem Cell Transplant (ASCT)
A Phase 2 study testing Elotuzumab, Melphalan and Autologous Stem Cell Transplant (ASCT) in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
This study will evaluate the ability of Expanded Natural Killer (ENK) cells to treat multiple myeloma when administered as part of a regimen consisting of Elotuzumab and a stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Elotuzumab, Melphalan and Autologous Stem Cell Transplant (ASCT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 8 Jul 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple myeloma patients that have completed induction chemotherapy and peripheral blood stem cell collection (PBSC) in preparation for ASCT.
- Patients must have high-risk disease as defined by Gene Expression Profiling (GEP) 70 risk score of ≥ 0.66 or GEP 80 gene score of ≥ 2.48 or metaphase cytogenetic abnormalities or lactate dehydrogenase (LDH) ≥ 360 U/L (Rule out hemolysis, infection and contact PI for clarification if any doubt).
- Patients must have failed prior treatment for their multiple myeloma (MM) including a proteasome inhibitor and immunomodulatory drug (so-called 'double refractory'). Patients who have received prior salvage combination chemotherapy after failure of proteasome inhibitor and immunomodulatory drug are eligible (frank relapse at the time of enrollment is not required)
- Zubrod ≤ 2, unless solely due to symptoms of MM-related (bone) disease.
- Patients must have a platelet count of ≥ 20,000/μL within 30 days of enrollment, unless lower levels are explained by extensive bone marrow plasmacytosis or extensive prior therapy.
- Patients must be at least 18 years of age and not older than 75 years of age at the time of registration.
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- must have preserved renal function as defined by a serum creatinine level of ≤ 3 mg/dL within 30 days of registration.
- Participants must have an ejection fraction by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan ≥ 40% within 90 days prior to registration.
- Patients must have adequate pulmonary function studies ≥ 50% of predicted on mechanical aspects and diffusion capacity (DLCO) ≥ 50% of predicted within 90 days prior to registration. If the patient is unable to complete pulmonary function tests due to MM-related pain or condition, exception may be granted if the principal investigator documents that the patient is a candidate for high-dose therapy.
- Patients must have at least 2x106 CD34+ cells/kg stored for transplant. In addition, there will be a 'back-up' available of 2x106 CD34+ cells/kg2x106 CD34+ cells/kg
- Patients must have signed an Institutional Review Board-approved informed consent and HIPAA authorization form.
Who cannot join
- Prior allo-transplant.
- Prior auto-transplantation is permitted provided the patient is still presently a transplant candidate and at least 2 months should have passed since last auto-transplant
- History of poorly-controlled hypertension, diabetes mellitus, or any other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or could be considered to be an exclusion criterion deemed by the PI.
- Patients must not have prior malignancy, except for adequately-treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. Other cancers will only be acceptable if the patient's life expectancy exceeds three years as determined by the PI.
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- The subject may not be positive for HIV I/II or HTLV-I/II.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: 2015-10: A Phase II Pilot Study of Expanded Natural Killer Cells and Elotuzumab to Eradicate High-Risk Myeloma Post Autologous Stem Cell Transplant
This study will evaluate the ability of Expanded Natural Killer (ENK) cells to treat multiple myeloma when administered as part of a regimen consisting of Elotuzumab and a stem cell transplant. Natural killer cells are a special type of white blood cells that are already present in the body which have the ability to kill myeloma cells. In this study, natural killer cells will be collected and then treated in a laboratory to activate and 'expand' the number of cells to increase the dose and the anti-myeloma activity of the cells before they are transfused back into the subject. Elotuzumab is a protein drug approved by the United States Food and Drug Administration (FDA) for patients with previously treated multiple myeloma and works by activating natural killer cells already present in the body and targeting a protein called SLAMF7 which is present on both natural killer cells and myeloma cells. The investigators hope that administering Elotuzumab in combination with ENK cells will enhance the anti-myeloma activity of the ENK cells.
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab, Melphalan, Autologous Stem Cell Transplant (ASCT), Expanded Natural Killer (ENK) Cells, ALT-803
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElotuzumabDrug
Also called Empliciti
Elotuzumab 10 mg/kg via intravenous infusion on days -16, -3, 12, and 26
MelphalanDrug
Melphalan 200 mg/m2 Ivia intravenous infusion on day -3
Autologous Stem Cell Transplant (ASCT)Procedure or surgery
ASCT on day -2
Expanded Natural Killer (ENK) CellsBiological
ENK cell infusion on day 0
ALT-803Drug
Also called IL-15 superagonist
ALT-803 (Interleukin-15 superagonist) 10 ug/kg via subcutaneous injection on days 1, 8, 15, and 22
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment | Experimental | Elotuzumab 10 mg/kg via intravenous infusion on days -16, -3, 12, and 26; Melphalan 200 mg/m2 Ivia intravenous infusion on day -3; ASCT on day -2; ENK infusion on day 0; ALT-803 (Interleukin-15 superagonist) 10 ug/kg via subcutaneous injection on days 1, 8, 15, and 22. Receives: Drug: Elotuzumab; Drug: Melphalan; Procedure: Autologous Stem Cell Transplant (ASCT); Biological: Expanded Natural Killer (ENK) Cells; Drug: ALT-803 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Myeloma Response
Response will be measured according to International Myeloma Working Group (IMWG) Criteria
Measured: 98 days post-ENK infusion (100 days post-ASCT)
Secondary outcomes (2)
Adverse Events
Frequency and severity of treatment-related adverse events
Measured: within 98 days post-ENK infusion (100 days post-ASCT)
Persistence of ENK cells by flow cytometry and/or cytometry by time of flight (CyTOF)
Measured: within 98 days post-ENK infusion (100 days post-ASCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start1 Nov 2019
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Why it stopped: Withdrawal of study support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Altor BioScience
- Responsible party
- Sponsor
- Investigators
- Frits van Rhee, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003728
- Sponsor's protocol ID
- 205009
- Status last verified
- Jul 2020
- First submitted
- 21 Dec 2016
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2015-10: A Phase II Pilot Study of Expanded Natural Killer Cells and Elotuzumab to Eradicate High-Risk Myeloma Post Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT03003728
- Acronym / sponsor ID
- 205009
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of study support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Altor BioScience
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 28 Dec 2016 (estimated)
- 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.
This study will evaluate the ability of Expanded Natural Killer (ENK) cells to treat multiple myeloma when administered as part of a regimen consisting of Elotuzumab and a stem cell transplant. Natural killer cells are a special type of white blood cells that are already present in the body which have the ability to kill myeloma cells. In this study, natural killer cells will be collected and then treated in a laboratory to activate and 'expand' the number of cells to increase the dose and the anti-myeloma activity of the cells before they are transfused back into the subject. Elotuzumab is a protein drug approved by the United States Food and Drug Administration (FDA) for patients with previously treated multiple myeloma and works by activating natural killer cells already present in the body and targeting a protein called SLAMF7 which is present on both natural killer cells and myeloma cells. The investigators hope that administering Elotuzumab in combination with ENK cells will enhance the anti-myeloma activity of the ENK cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment | Experimental | Drug: Elotuzumab, Drug: Melphalan, Procedure: Autologous Stem Cell Transplant (ASCT), Biological: Expanded Natural Killer (ENK) Cells, Drug: ALT-803Elotuzumab 10 mg/kg via intravenous infusion on days -16, -3, 12, and 26; Melphalan 200 mg/m2 Ivia intravenous infusion on day -3; ASCT on day -2; ENK infusion on day 0; ALT-803 (Interleukin-15 superagonist) 10 ug/kg via subcutaneous injection on days 1, 8, 15, and 22. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Multiple myeloma patients that have completed induction chemotherapy and peripheral blood stem cell collection (PBSC) in preparation for ASCT.
- Patients must have high-risk disease as defined by Gene Expression Profiling (GEP) 70 risk score of ≥ 0.66 or GEP 80 gene score of ≥ 2.48 or metaphase cytogenetic abnormalities or lactate dehydrogenase (LDH) ≥ 360 U/L (Rule out hemolysis, infection and contact PI for clarification if any doubt).
- Patients must have failed prior treatment for their multiple myeloma (MM) including a proteasome inhibitor and immunomodulatory drug (so-called 'double refractory'). Patients who have received prior salvage combination chemotherapy after failure of proteasome inhibitor and immunomodulatory drug are eligible (frank relapse at the time of enrollment is not required)
- Zubrod ≤ 2, unless solely due to symptoms of MM-related (bone) disease.
- Patients must have a platelet count of ≥ 20,000/μL within 30 days of enrollment, unless lower levels are explained by extensive bone marrow plasmacytosis or extensive prior therapy.
Key exclusion criteria (6 listed)
- Prior allo-transplant.
- Prior auto-transplantation is permitted provided the patient is still presently a transplant candidate and at least 2 months should have passed since last auto-transplant
- History of poorly-controlled hypertension, diabetes mellitus, or any other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or could be considered to be an exclusion criterion deemed by the PI.
- Patients must not have prior malignancy, except for adequately-treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. Other cancers will only be acceptable if the patient's life expectancy exceeds three years as determined by the PI.
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
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: EmplicitiElotuzumab 10 mg/kg via intravenous infusion on days -16, -3, 12, and 26 | Drug | Study Treatment |
| MelphalanMelphalan 200 mg/m2 Ivia intravenous infusion on day -3 | Drug | Study Treatment |
| Autologous Stem Cell Transplant (ASCT)ASCT on day -2 | Procedure or surgery | Study Treatment |
| Expanded Natural Killer (ENK) CellsENK cell infusion on day 0 | Biological | Study Treatment |
| ALT-803Also: IL-15 superagonistALT-803 (Interleukin-15 superagonist) 10 ug/kg via subcutaneous injection on days 1, 8, 15, and 22 | Drug | Study Treatment |
Primary outcome
Multiple Myeloma Response
Time frame: 98 days post-ENK infusion (100 days post-ASCT)
Response will be measured according to International Myeloma Working Group (IMWG) Criteria
2 secondary outcomes
Adverse Events
Time frame: within 98 days post-ENK infusion (100 days post-ASCT)
Persistence of ENK cells by flow cytometry and/or cytometry by time of flight (CyTOF)
Time frame: within 98 days post-ENK infusion (100 days post-ASCT)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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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.
Frits van Rhee, MD, PhD principal investigator
University of Arkansas
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, Melphalan and Autologous Stem Cell Transplant (ASCT) in people with Multiple Myeloma, run by University of Arkansas 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 11 inclusion and 6 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: withdrawn, as of the sponsor's last update on 10 Jul 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Multiple Myeloma Response (time frame: 98 days post-ENK infusion (100 days post-ASCT)). 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 10 Jul 2020.