Multiple MyelomaPhase 2Immuno-POWERNCT04584307

Phase II Study of Immunomaintenance Using POmalidomide With Elotuzumab afteR Second Autologous Transplant

A Phase 2 study testing Elotuzumab and Pomalidomide in people with Multiple Myeloma, run by Natalie Callendar.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The purpose of this clinical trial is to examine the role of an immune modulatory drug (IMID) in combination with elotuzumab, in a lenalidomide-free approach to maintenance therapy following second unplanned autologous peripheral blood stem cell transplant (PBSCT) for relapsed multiple myeloma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Elotuzumab and Pomalidomide
Type of treatment: 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: Apr 2021to Dec 2024
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a diagnosis of relapsed or relapsed/refractory multiple myeloma who will be undergoing a second unplanned autologous peripheral blood stem cell transplant for their disease.
Age ≥ 18 years at the time of consent.
Written informed consent and HIPAA authorization for release of personal health information.
NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
ECOG Performance Status of 0, 1, or 2 within 14 days prior to registration.
Patients must have had measurable disease, defined as one of the following:

Show all 24Show fewer

monoclonal protein (M-protein): ≥ 0.5g/dL on serum protein electrophoresis or ≥ 200 mg of monoclonal protein on a 24-hour urine protein or involved serum light chain ≥ 10 mg/dl at time of relapse, leading to decision to proceed to transplant; or
biopsy proven plasmacytoma that can be assessed by physical exam or imaging; or
if non-secretory, ≥10% plasma cells on BM biopsy/aspirate at time of relapse or plasmacytoma as described above.
NOTE: Urine protein electrophoresis (UPEP) (on a 24-h collection) is required, no substitute method is acceptable. Urine must be assessed to establish response if the baseline urine M-spike is ≥ 200 mg/24 h at the time of enrollment. Please note that if both serum and urine M-components are present prior to transplant, both should be assessed in order to evaluate response.
Patients may have received any number and type of previous treatments for myeloma including elotuzumab or pomalidomide, but not simultaneous administration of these two agents.
Previous allogeneic transplant is allowed provided the patient is not receiving ongoing therapy for GVHD.
Previous CAR-T transplantation or other BMCA directed therapy is also allowed provided there is no evidence of residual cytokine release syndrome or cytokine release encephalopathy syndrome.
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Pomalidomide will not be provided the study and therefore study subjects must have confirmed access to pomalidomide for use during the study established at time of enrollment.
Furthermore, subjects must meet all of the following applicable inclusion criteria 45-90 days post-transplant to be treated on this study:
Patients must have recovered from transplantation to ≤grade 2 non- hematologic toxicity, with the exception of alopecia.
No evidence of progression of myeloma noted within 45 days post-transplant.
Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 14 days prior to initiation of treatment.
Females of childbearing potential must have two negative pregnancy tests (serum or urine): within 14 days and 24 hours prior to treatment.
-- NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 5 months for females, and 7 months for males after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method. Interventions such as IUD, tubal ligation, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, all count as one method. For WOCBP, a second form must also be used.
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Subjects must be willing to provide BM, stool and blood samples during the study period.

Who cannot join

Active infection requiring systemic therapy.
Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least three years. Patients who have undergone a curative procedure for another malignancy are eligible.
Active central nervous system (CNS) metastases.
Treatment with any investigational drug within 30 days prior to registration.
Planned transplant is considered part of tandem approach for newly diagnosed MM
History of severe hypersensitivity reaction to any monoclonal antibody.

Show all 10Show fewer

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because pomalidomide is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pomalidomide, breastfeeding should be discontinued if the mother is treated with pomalidomide.
Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) might be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with/without active treatment and absolute lymphocyte count >= 350/ul. Such subjects may stay on antiviral therapy during study treatment.
Patients with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment. Such patients may stay on viral therapy while on treatment.

About this study

Official title: Phase II Study of Immunomaintenance Using POmalidomide With Elotuzumab afteR Second Autologous Transplant (Immuno-POWER Trial): Big Ten Cancer Research Consortium BTCRC-MM19-428

Conditions: Multiple Myeloma
Being tested: Elotuzumab, Pomalidomide
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
Elotuzumab 10-20mg/kg
PomalidomideDrug
Pomalidomide 2mg

Study groups in NCT04584307
Study group	Role	What they receive
Elotuzumab + Pomalidomide	Experimental	Elotuzumab, 10 mg/kg IV, Days 1,8,15,22 for cycles 1 and 2 Elotuzumab, 20 mg/kg IV, Day 1 for cycles 3 + Pomalidomide 2mg PO, Day 1-21 for all cycles Receives: Drug: Elotuzumab; Drug: Pomalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival
To estimate progression-free survival (PFS) rate in patients receiving the combination of elotuzumab and pomalidomide who have undergone a second unplanned autologous PBSCT for relapsed multiple myeloma (MM).
Measured: From enrollment until the time of disease progression, up to 36 months

Secondary outcomes (2)

Overall Survival
To estimate overall survival (OS) rate in patients receiving the combination of elotuzumab and pomalidomide who have undergone a second unplanned autologous PBSCT for relapsed MM.
Measured: From enrollment until the time of death, up to 36 months
Summary of >= Grade 3 Hematologic and Non-Hematologic Toxicities
The number and frequency of toxicities will be summarized by type and severity in tabular format. The rates of grade ≥3 hematologic and non-hematologic toxicities will be reported along with the corresponding 95% confidence intervals (CI) which will be constructed using the Wilson score method.
Measured: From enrollment until treatment discontinuation, up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2021Dec 2024

First posted12 Oct 2020
Study startApr 2021 (estimated)
Primary completionDec 2023 (estimated)
Study completionDec 2024 (estimated)

Why it stopped: Funder pulled support/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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04584307
Sponsor's protocol ID: BTCRC-MM19-428
Acronym: Immuno-POWER
Status last verified: Aug 2021
First submitted: 6 Oct 2020
Last updated: 23 Aug 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Immunomaintenance Using POmalidomide With Elotuzumab afteR Second Autologous Transplant (Immuno-POWER Trial): Big Ten Cancer Research Consortium BTCRC-MM19-428
ClinicalTrials.gov ID: NCT04584307
Acronym / sponsor ID: Immuno-POWER / BTCRC-MM19-428
Conditions: Multiple Myeloma
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Funder pulled support/funding
Enrolment: 0 participants (actual)
Lead sponsor: Natalie CallendarUniversity, hospital or other
Collaborators: Bristol-Myers Squibb
Study start: Apr 2021 (estimated)
Primary completion: Dec 2023 (estimated)
Study completion: Dec 2024 (estimated)
First posted: 12 Oct 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Elotuzumab + Pomalidomide	Experimental	Drug: Elotuzumab, Drug: PomalidomideElotuzumab, 10 mg/kg IV, Days 1,8,15,22 for cycles 1 and 2 Elotuzumab, 20 mg/kg IV, Day 1 for cycles 3 + Pomalidomide 2mg PO, Day 1-21 for all cycles

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

Patients with a diagnosis of relapsed or relapsed/refractory multiple myeloma who will be undergoing a second unplanned autologous peripheral blood stem cell transplant for their disease.
Age ≥ 18 years at the time of consent.
Written informed consent and HIPAA authorization for release of personal health information.
NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
ECOG Performance Status of 0, 1, or 2 within 14 days prior to registration.

Key exclusion criteria (10 listed)

Active infection requiring systemic therapy.
Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least three years. Patients who have undergone a curative procedure for another malignancy are eligible.
Active central nervous system (CNS) metastases.
Treatment with any investigational drug within 30 days prior to registration.
Planned transplant is considered part of tandem approach for newly diagnosed MM

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
ElotuzumabElotuzumab 10-20mg/kg	Drug	Elotuzumab + Pomalidomide
PomalidomidePomalidomide 2mg	Drug	Elotuzumab + Pomalidomide

Primary outcome

Progression-Free Survival
Time frame: From enrollment until the time of disease progression, up to 36 months
To estimate progression-free survival (PFS) rate in patients receiving the combination of elotuzumab and pomalidomide who have undergone a second unplanned autologous PBSCT for relapsed multiple myeloma (MM).

2 secondary outcomes

Overall Survival
Time frame: From enrollment until the time of death, up to 36 months
Summary of >= Grade 3 Hematologic and Non-Hematologic Toxicities
Time frame: From enrollment until treatment discontinuation, up to 18 months

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 23 Aug 2021.
Individual participant dataSharing planned: No

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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.

Natalie Callendar, MD principal investigator

University of Wisconsin, Madison

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elotuzumab and Pomalidomide in people with Multiple Myeloma, run by Natalie Callendar.

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 24 inclusion and 10 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 23 Aug 2021. 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?

Progression-Free Survival (time frame: From enrollment until the time of disease progression, up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04584307.

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 23 Aug 2021.