Multiple MyelomaPhase 2NCT03168100
2017-03: A Single-Arm, Open-label Study of Anti-Signaling Lymphocytic Activation Molecule F7 (Anti-SLAMF7) Monoclonal Antibody (mAb) Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma
A Phase 2 study testing Elotuzumab, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
The Total Therapy treatment regimens developed at the Myeloma Institute have demonstrated great improvement in treatment outcomes for multiple myeloma patients. However, some patients still relapse early during maintenance treatment meaning that better options are still needed. 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, 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 24 Jan 2019
- 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
- Patients must be at least 18 years of age and not older than 75 years of age at the time of enrollment.
- Patients must have completed a stem cell transplant regimen for newly diagnosed multiple myeloma (MM) consisting of (at least) induction chemotherapy and single or tandem autologous stem cell transplant (ASCT) within eight months of study enrollment. The completed regimen may have included post-transplant consolidation therapy, but post-transplant consolidation is not required.
- Patients must have achieved at least a partial response (PR) (according to International Myeloma Working Group (IMWG) criteria) in response to the completed transplant regimen.
- ECOG ≤ 2 (ECOG of 3 allowed if solely due to symptoms of MM-related bone disease).
- Patients must have absolute neutrophil count (ANC) ≥ 1,000/mm3 and a platelet count of ≥ 75,000/μL.
- Patients must have a baseline serum creatinine level of < 3 mg/dL and baseline alanine aminotransferase (ALT) < 3x Upper limit of normal (ULN)
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- Toxicities related to prior therapies must be resolved to ≤ Grade 2 according to NCI Common Terminology for Adverse Events (CTCAE) Version 4.
- Female patients must be:
- Postmenopausal for at least 1 year before the screening visit, OR
- Surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 simultaneous effective methods of contraception, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Male patients, even if surgically sterilized (ie, post-vasectomy) must agree to one of the following:
- Practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
- Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Patients must sign an Institutional Review Board (IRB)-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the IRB.
Who cannot join
- Female patients who are nursing or pregnant may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of beginning study treatment. Refer to the Revlimid Risk Evaluation and Mitigation Strategies (REMS) program for more information.
- History of poorly controlled hypertension, diabetes mellitus, active or uncontrolled hepatitis, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol, or that in the opinion of the investigator would constitute a hazard for participating in this study.
- History of clinically significant cardiac disease as determined by the enrolling physician including cardiac amyloidosis.
- 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 be acceptable if the patient's life expectancy exceeds five years.
- Known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins or any of the study medications, their analogues, or excipients in the various formulations of any agent (refer to the latest versions of the package inserts).
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: University of Arkansas (UARK# 2017-03): A Single-Arm, Open-label Study of Anti-SLAMF7 mAb Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma (Total Therapy 8)
The Total Therapy treatment regimens developed at the Myeloma Institute have demonstrated great improvement in treatment outcomes for multiple myeloma patients. However, some patients still relapse early during maintenance treatment meaning that better options are still needed. This study will evaluate a treatment regimen that alternates two different 3-drug regimens every eight weeks for patients that have previously completed autologous stem cell transplant. The two regimens are bortezomib, lenalidomide, and dexamethasone (VRD) which will be alternated with Elotuzumab, lenalidomide, and dexamethasone (Elo RD). Effectiveness will be measured by the depth of response (i.e., whether or not minimal residual disease (MRD) negative status is achieved). The rate of MRD negativity from this study will be compared to historical control data from the Total Therapy 4 trial which used continuous VRD maintenance therapy after stem cell transplant(s).
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab, Lenalidomide, Dexamethasone, Bortezomib
- 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
administered via IV infusion
LenalidomideDrug
Also called Revlimid
taken by mouth
DexamethasoneDrug
Also called Decadron
taken by mouth
BortezomibDrug
Also called Velcade
administered as a subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment | Experimental | Elotuzumab (10 mg Days 1 and 15), lenalidomide (15 mg Days 1-21), and dexamethasone (20 mg days 1, 8, 15, and 22) administered in 28-day cycles which will be alternated every 8 weeks with bortezomib (1.0 mg Days 1, 8, and 15), lenalidomide (15 mg Days 1-21), and dexamethasone (20 mg Days 1, 8, 15, and 22) Receives: Drug: Elotuzumab; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of Response
Depth of response will be measured by minimal residual disease (MRD) status (i.e., positive or negative).
Measured: Six months from start of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Oct 2017
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Why it stopped: No study population. No subjects enrolled.
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
- Responsible party
- Sponsor
- Investigators
- Faith Davies, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168100
- Sponsor's protocol ID
- 206603
- Status last verified
- Jan 2019
- First submitted
- 24 May 2017
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Arkansas (UARK# 2017-03): A Single-Arm, Open-label Study of Anti-SLAMF7 mAb Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma (Total Therapy 8)
- ClinicalTrials.gov ID
- NCT03168100
- Acronym / sponsor ID
- 206603
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No study population. No subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 30 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 Total Therapy treatment regimens developed at the Myeloma Institute have demonstrated great improvement in treatment outcomes for multiple myeloma patients. However, some patients still relapse early during maintenance treatment meaning that better options are still needed. This study will evaluate a treatment regimen that alternates two different 3-drug regimens every eight weeks for patients that have previously completed autologous stem cell transplant. The two regimens are bortezomib, lenalidomide, and dexamethasone (VRD) which will be alternated with Elotuzumab, lenalidomide, and dexamethasone (Elo RD). Effectiveness will be measured by the depth of response (i.e., whether or not minimal residual disease (MRD) negative status is achieved). The rate of MRD negativity from this study will be compared to historical control data from the Total Therapy 4 trial which used continuous VRD maintenance therapy after stem cell transplant(s).
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: Lenalidomide, Drug: Dexamethasone, Drug: BortezomibElotuzumab (10 mg Days 1 and 15), lenalidomide (15 mg Days 1-21), and dexamethasone (20 mg days 1, 8, 15, and 22) administered in 28-day cycles which will be alternated every 8 weeks with bortezomib (1.0 mg Days 1, 8, and 15), lenalidomide (15 mg Days 1-21), and dexamethasone (20 mg 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 (16 listed)
- Patients must be at least 18 years of age and not older than 75 years of age at the time of enrollment.
- Patients must have completed a stem cell transplant regimen for newly diagnosed multiple myeloma (MM) consisting of (at least) induction chemotherapy and single or tandem autologous stem cell transplant (ASCT) within eight months of study enrollment. The completed regimen may have included post-transplant consolidation therapy, but post-transplant consolidation is not required.
- Patients must have achieved at least a partial response (PR) (according to International Myeloma Working Group (IMWG) criteria) in response to the completed transplant regimen.
- ECOG ≤ 2 (ECOG of 3 allowed if solely due to symptoms of MM-related bone disease).
- Patients must have absolute neutrophil count (ANC) ≥ 1,000/mm3 and a platelet count of ≥ 75,000/μL.
Key exclusion criteria (5 listed)
- Female patients who are nursing or pregnant may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of beginning study treatment. Refer to the Revlimid Risk Evaluation and Mitigation Strategies (REMS) program for more information.
- History of poorly controlled hypertension, diabetes mellitus, active or uncontrolled hepatitis, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol, or that in the opinion of the investigator would constitute a hazard for participating in this study.
- History of clinically significant cardiac disease as determined by the enrolling physician including cardiac amyloidosis.
- 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 be acceptable if the patient's life expectancy exceeds five years.
- Known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins or any of the study medications, their analogues, or excipients in the various formulations of any agent (refer to the latest versions of the package inserts).
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: Emplicitiadministered via IV infusion | Drug | Study Treatment |
| LenalidomideAlso: Revlimidtaken by mouth | Drug | Study Treatment |
| DexamethasoneAlso: Decadrontaken by mouth | Drug | Study Treatment |
| BortezomibAlso: Velcadeadministered as a subcutaneous injection | Drug | Study Treatment |
Primary outcome
Depth of Response
Time frame: Six months from start of study treatment.
Depth of response will be measured by minimal residual disease (MRD) status (i.e., positive or negative).
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 28 Jan 2019.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data.
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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.
Faith Davies, MD 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, Lenalidomide and Dexamethasone 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 16 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: withdrawn, as of the sponsor's last update on 28 Jan 2019. 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?
Depth of Response (time frame: Six months from start of study treatment.). 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 28 Jan 2019.