Asymptomatic Multiple MyelomaPhase 2NCT01884688
UARK 2013-05 A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
A Phase 2 study testing ENK Cell Infusion in people with Asymptomatic Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and in vivo persistence and expansion of autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asymptomatic Multiple Myeloma
- What is being tested?
- ENK Cell Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Oct 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study population will be participants with AMM being seen at Myeloma Institute for Research and Therapy (MIRT), and under continuing followup with standard clinical care testing .
- Participants must have a diagnosis of AMM as defined in Staging Criteria (Section 3.0) and GEP-70 score >-0.26.
- Participant (male or female) from any race or ethnicity must be at least 18 years of age and not older than 75 years of age at the time of registration.
- Participants must have a performance status of 0 - 2 by Zubrod criteria
- Participants must have signed an Institutional Review Board (IRB)-approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form.
- Must be fit to undergo leukapheresis for ENK cell generation as determined by PI.
- Must be a suitable candidate for insertion of apheresis catheter. Participants with unusual anatomy or vascular anomalies preventing insertion of apheresis catheter will not qualify.
- Patients must have previous test results indicating adequate pulmonary function studies (PFT) > 50% of predicted on mechanical aspects (FEV1, forced vital capacity(FVC), etc) and diffusion capacity (DLCO) > 50% of predicted.
Who cannot join
- Participants must not have received prior treatment for their disease. Prior use of bisphosphonates is permitted.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 2 years.
- May not have 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.
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within 10 to 14 days of enrollment. Women/men of reproductive potential may not participate unless they have either agreed to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg,calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) OR begin TWO reliable methods of birth control: 1 highly effective method and 1 additional effective method AT THE SAME TIME, at least 28 days before starting study treatment through 30 days after the last dose of study treatment.
- Serologic evaluation will be used to assess exposure to syphilis, West Nile Virus, Chagas, cytomegalovirus (CMV), Immunoglobulin G (IgG), hepatitis B, and C, HIV I and II, and human t cell lymphoma virus (HTLV) I/II. Participants may not be hepatitis B or C (+) unless positive due to previous vaccination or positive but has received therapy and is negative for hepatitis B or C by rapid test polymerase chain reaction (RT-PCR). An HIV-I/II(+) and HTLV-1/II (+) participant will be rejected on medical grounds. Participants serologically positive for syphilis, West Nile Virus, Chagas, CMV, are only excluded if they are being treated for active infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205
About this study
Official title: A Phase II Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
The purpose of this study is to determine the safety and in vivo persistence and expansion of autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells.
Read the detailed description
To determine whether significant in vivo expansion of auto-ENK cells occurs, defined as a > 4 fold increase in absolute cluster of differentiation 3(CD3)-cluster of differentiation 56 (CD56+) NK cell count/blood 7 days after infusion over the pre-study baseline level and the safety of the ENK cell therapy in research participants with high-risk asymptomatic multiple myeloma (AMM) defined as gene expression profile (GEP) 70 gene score>-0.26.
- Conditions
- Asymptomatic Multiple Myeloma
- Being tested
- ENK Cell Infusion
- Keywords
- Asymptomatic Multiple Myeloma, Auto-ENK Cell Therapy, Natural Killer Cells
- 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.
ENK Cell InfusionDrug
Also called Auto-ENK Cell Therapy
Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
| Study group | Role | What they receive |
|---|---|---|
| ENK Cell Infusion | Experimental | Expanded Natural Killer Cell Infusion Receives: Drug: ENK Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment
Number of participants with at least 4 fold increase in absolute CD3-CD56+ NK cell count/uL blood 7 days after infusion over the pre-study baseline level
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2016
- Study completionOct 2016
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.
- Other trials for Asymptomatic 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Frits Van Rhee, M.D., Phd, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884688
- Sponsor's protocol ID
- 138826
- Status last verified
- Mar 2017
- First submitted
- 10 Jun 2013
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01884688
- Acronym / sponsor ID
- 138826
- Conditions
- Asymptomatic Multiple Myeloma
- Keywords
- Asymptomatic Multiple Myeloma, Auto-ENK Cell Therapy, Natural Killer Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Apr 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and in vivo persistence and expansion of autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells.
Detailed description
To determine whether significant in vivo expansion of auto-ENK cells occurs, defined as a > 4 fold increase in absolute cluster of differentiation 3(CD3)-cluster of differentiation 56 (CD56+) NK cell count/blood 7 days after infusion over the pre-study baseline level and the safety of the ENK cell therapy in research participants with high-risk asymptomatic multiple myeloma (AMM) defined as gene expression profile (GEP) 70 gene score>-0.26.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENK Cell Infusion | Experimental | Drug: ENK Cell InfusionExpanded Natural Killer Cell Infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The study population will be participants with AMM being seen at Myeloma Institute for Research and Therapy (MIRT), and under continuing followup with standard clinical care testing .
- Participants must have a diagnosis of AMM as defined in Staging Criteria (Section 3.0) and GEP-70 score >-0.26.
- Participant (male or female) from any race or ethnicity must be at least 18 years of age and not older than 75 years of age at the time of registration.
- Participants must have a performance status of 0 - 2 by Zubrod criteria
- Participants must have signed an Institutional Review Board (IRB)-approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form.
Key exclusion criteria (5 listed)
- Participants must not have received prior treatment for their disease. Prior use of bisphosphonates is permitted.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 2 years.
- May not have 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.
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within 10 to 14 days of enrollment. Women/men of reproductive potential may not participate unless they have either agreed to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg,calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) OR begin TWO reliable methods of birth control: 1 highly effective method and 1 additional effective method AT THE SAME TIME, at least 28 days before starting study treatment through 30 days after the last dose of study treatment.
- Serologic evaluation will be used to assess exposure to syphilis, West Nile Virus, Chagas, cytomegalovirus (CMV), Immunoglobulin G (IgG), hepatitis B, and C, HIV I and II, and human t cell lymphoma virus (HTLV) I/II. Participants may not be hepatitis B or C (+) unless positive due to previous vaccination or positive but has received therapy and is negative for hepatitis B or C by rapid test polymerase chain reaction (RT-PCR). An HIV-I/II(+) and HTLV-1/II (+) participant will be rejected on medical grounds. Participants serologically positive for syphilis, West Nile Virus, Chagas, CMV, are only excluded if they are being treated for active infection.
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 |
|---|---|---|
| ENK Cell InfusionAlso: Auto-ENK Cell TherapyDay 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU | Drug | ENK Cell Infusion |
Primary outcome
Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment
Time frame: 7 days
Number of participants with at least 4 fold increase in absolute CD3-CD56+ NK cell count/uL blood 7 days after infusion over the pre-study baseline level
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, M.D., 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 ENK Cell Infusion in people with Asymptomatic 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 8 inclusion and 5 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 17 Apr 2017. 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 17 Apr 2017). 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?
Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment (time frame: 7 days). 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 17 Apr 2017.