Multiple MyelomaPhase 2NCT03000634
2015-09: a Phase II Randomized, Open-label Study of Anti-signaling Lymphocytic Activation Molecule Monoclonal Antibody During Maintenance Therapy
A Phase 2 study testing Elotuzumab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by University of Arkansas.
Trial summary
This study will compare the effectiveness and safety of maintenance therapy with continuous bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks. 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, Bortezomib and Lenalidomide
- 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
- No sites listed yet
- Study dates
- 1 Apr 2017to 1 Apr 2017
- 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 Total Therapy-like treatment regimen for newly diagnosed multiple myeloma consisting of induction chemotherapy and stem cell transplant within 4 months of study enrollment. The completed regimen may have also included post-transplant consolidation therapy, but post-transplant consolidation is not required. The regimen must have included, at minimum, a proteasome inhibitor, an immunomodulatory agent, and a corticosteroid.
- Patients must have low-risk disease, defined as an existing myeloma prognostic risk score risk score < 50.4 from a prior bone marrow biopsy sample in which plasma cells were present.
- Patients must have high risk cytogenetic abnormalities, defined as one or more of the following chromosomal aberrations detected by fluorescent in situ hybridization: 17p-, 1q+, t(4;14) and t(14;16).
- Eastern Cooperative Oncology Group ≤ 2, unless solely due to symptoms of multiple myeloma-related bone disease.
- Patients must have absolute neutrophil count(ANC) ≥ 1,000/mm3 and a platelet count of ≥ 100,000/µL, unless lower levels are due to extensive bone marrow plasmacytosis.
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- Patients must have a baseline serum creatinine level of < 3 mg/dL and baseline alanine aminotransferase (ALT) < 3x Upper limit of normal (ULN)
- 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 IRB-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the Institutional Review Board (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 Management Strategy (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.
- Known Chronic obstructive pulmonary disease with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal. Note that FEV1(forced expiratory volume in 1 second) testing is required for patients suspected of having chronic obstructive pulmonary disease.
- Clinically significant cardiac disease, including: myocardial infarction within one year prior to study enrollment or history of unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV); cardiac arrhythmia ≥ Grade 2 or clinical significant electrocardiogram abnormalities.
- 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).
About this study
Official title: 2015-09: a Phase II Randomized, Open-label Study of Anti-SLAMF7 MAb During Maintenance Therapy Versus Standard Maintenance Therapy in Gene Expression Profiling (GEP)- Defined Low Risk Multiple Myeloma Patients with High Risk Cytogenetic Abnormalities
This study will compare the effectiveness and safety of maintenance therapy with continuous bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks.
Read the detailed description
Past studies conducted at the Myeloma Institute have shown that many patients with low-risk disease (as determined by gene array studies - studies that look at specific genes using special equipment) respond very well to treatment. However, about 15% of low-risk patients still relapse during the first three years of treatment, which means that better treatments are still needed.
This study will compare the effectiveness and safety of maintenance therapy with continuous bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks.
Elotuzumab, bortezomib, lenalidomide and dexamethasone are all approved by the FDA for the treatment of patients with multiple myeloma. VRD is the standard maintenance regimen prescribed at the University of Arkansas for Medical Sciences (UAMS) Myeloma Institute for patients with low risk disease. The investigators want to learn if alternating VRD with Elo RD during maintenance therapy will result in better outcomes.
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab, Bortezomib, Lenalidomide, Dexamethasone
- 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 Elo
Administered through a small tube that goes directly into the vein
BortezomibDrug
Also called Velcade
Administered as a subcutaneous injection under the skin
LenalidomideDrug
Also called Revlimid
Capsule taken by mouth
DexamethasoneDrug
Also called Decadron
Taken by mouth
| Study group | Role | What they receive |
|---|---|---|
| Anti-SLAMF7 mAb+RD alternating every 8 wks with VRD | Experimental | Elotuzumab 10 mg day 1,15 Lenalidomide 25 mg day 1-21 Dexamethasone 20 mg day 1,8,15,22 Bortezomib 1.3 mg day 1,8,15 Receives: Drug: Elotuzumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone |
| VRD-bortezomib, lenalidomide, dexamethasone | Other | Bortezomib 1.3 mg day 1, 8,15 Lenalidomide 25 mg day 1-21 Dexamethasone 20 mg day 1, 8,15,22 Receives: Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients without disease progression within 36 months from start of study treatment.
Progression-Free Survival (PFS)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start1 Apr 2017
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Why it stopped: Study was not and will not be initiated due to lack of funding.
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- 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 E Davies, MD, Principal investigator, University of Arkansas for Medical Science-Myeloma Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000634
- Sponsor's protocol ID
- 204814
- Status last verified
- Apr 2017
- First submitted
- 7 Dec 2016
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2015-09: a Phase II Randomized, Open-label Study of Anti-SLAMF7 MAb During Maintenance Therapy Versus Standard Maintenance Therapy in Gene Expression Profiling (GEP)- Defined Low Risk Multiple Myeloma Patients with High Risk Cytogenetic Abnormalities
- ClinicalTrials.gov ID
- NCT03000634
- Acronym / sponsor ID
- 204814
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not and will not be initiated due to lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 22 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 compare the effectiveness and safety of maintenance therapy with continuous bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks.
Detailed description
Past studies conducted at the Myeloma Institute have shown that many patients with low-risk disease (as determined by gene array studies - studies that look at specific genes using special equipment) respond very well to treatment. However, about 15% of low-risk patients still relapse during the first three years of treatment, which means that better treatments are still needed.
This study will compare the effectiveness and safety of maintenance therapy with continuous bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks.
Elotuzumab, bortezomib, lenalidomide and dexamethasone are all approved by the FDA for the treatment of patients with multiple myeloma. VRD is the standard maintenance regimen prescribed at the University of Arkansas for Medical Sciences (UAMS) Myeloma Institute for patients with low risk disease. The investigators want to learn if alternating VRD with Elo RD during maintenance therapy will result in better outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-SLAMF7 mAb+RD alternating every 8 wks with VRD | Experimental | Drug: Elotuzumab, Drug: Bortezomib, Drug: Lenalidomide, Drug: DexamethasoneElotuzumab 10 mg day 1,15 Lenalidomide 25 mg day 1-21 Dexamethasone 20 mg day 1,8,15,22 Bortezomib 1.3 mg day 1,8,15 |
| VRD-bortezomib, lenalidomide, dexamethasone | Other | Drug: Bortezomib, Drug: Lenalidomide, Drug: DexamethasoneBortezomib 1.3 mg day 1, 8,15 Lenalidomide 25 mg day 1-21 Dexamethasone 20 mg day 1, 8,15,22 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 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 Total Therapy-like treatment regimen for newly diagnosed multiple myeloma consisting of induction chemotherapy and stem cell transplant within 4 months of study enrollment. The completed regimen may have also included post-transplant consolidation therapy, but post-transplant consolidation is not required. The regimen must have included, at minimum, a proteasome inhibitor, an immunomodulatory agent, and a corticosteroid.
- Patients must have low-risk disease, defined as an existing myeloma prognostic risk score risk score < 50.4 from a prior bone marrow biopsy sample in which plasma cells were present.
- Patients must have high risk cytogenetic abnormalities, defined as one or more of the following chromosomal aberrations detected by fluorescent in situ hybridization: 17p-, 1q+, t(4;14) and t(14;16).
- Eastern Cooperative Oncology Group ≤ 2, unless solely due to symptoms of multiple myeloma-related bone disease.
Key exclusion criteria (7 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 Management Strategy (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.
- Known Chronic obstructive pulmonary disease with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal. Note that FEV1(forced expiratory volume in 1 second) testing is required for patients suspected of having chronic obstructive pulmonary disease.
- Clinically significant cardiac disease, including: myocardial infarction within one year prior to study enrollment or history of unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV); cardiac arrhythmia ≥ Grade 2 or clinical significant electrocardiogram abnormalities.
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: EloAdministered through a small tube that goes directly into the vein | Drug | Anti-SLAMF7 mAb+RD alternating every 8 wks with VRD |
| BortezomibAlso: VelcadeAdministered as a subcutaneous injection under the skin | Drug | Anti-SLAMF7 mAb+RD alternating every 8 wks with VRD, VRD-bortezomib, lenalidomide, dexamethasone |
| LenalidomideAlso: RevlimidCapsule taken by mouth | Drug | Anti-SLAMF7 mAb+RD alternating every 8 wks with VRD, VRD-bortezomib, lenalidomide, dexamethasone |
| DexamethasoneAlso: DecadronTaken by mouth | Drug | Anti-SLAMF7 mAb+RD alternating every 8 wks with VRD, VRD-bortezomib, lenalidomide, dexamethasone |
Primary outcome
Percentage of patients without disease progression within 36 months from start of study treatment.
Time frame: 36 months
Progression-Free Survival (PFS)
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 5 Sep 2024.
- 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.
Faith E Davies, MD principal investigator
University of Arkansas for Medical Science-Myeloma Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elotuzumab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by University of Arkansas.
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 17 inclusion and 7 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of patients without disease progression within 36 months from start of study treatment. (time frame: 36 months). 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 5 Sep 2024.