Plasma Cell MyelomaPhase 2NCT03756896
Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma
A Phase 2 study testing Carfilzomib, Dexamethasone and Pomalidomide in people with Plasma Cell Myeloma, run by Emory University at 1 site in United States.
Trial summary
This phase II trial studies how well carfilzomib, pomalidomide, and dexamethasone work in treating patients with high-risk multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Carfilzomib, Dexamethasone and Pomalidomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 must meet the following criteria on screening examination to be eligible to participate in the study; all laboratory assessments should be performed within 28 days of initiation of protocol therapy unless otherwise specified; subject is, in the investigator's opinion, willing and able to comply with the protocol requirements
- Subject has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
- Subject is a transplant-eligible patient that have undergone autologous stem cell transplant (ASCT) within one year of their diagnosis and have achieved ≥ partial response (PR) based on International Myeloma Working Group (IMWG) standard criteria
- Patients with high risk disease defined as
- Presence of del(17p); t(4;14); t(14;16); t(14;20) by fluorescence in situ hybridization (FISH) or by cytogenetics (CTG)
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- Plasma cell leukemia at diagnosis with ≥ 20% circulating plasma cells on peripheral blood
- Subject agrees to refrain from blood donations during therapy on study and for 90 days after therapy is completed
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International units (mIU)/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide through 90 days after the last dose of study drug; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 90 days after the last dose of study drug; all patients must be registered in and must comply with all requirements of the pomalidomide Risk Evaluation and Mitigation Strategies (REMS) program; male subjects should refrain from sperm donation for at least 90 days after the last dose of carfilzomib or pomalidomide
- FCBP refers to sexually mature female, regardless of sexual orientation or whether they have undergone tubal ligation, who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally menopausal for at least 24 consecutive months
Who cannot join
- Diagnosed with smoldering multiple myeloma (MM), monoclonal gammopathy of undetermined significance, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis or standard risk myeloma or secondary plasma cell leukemia
- High risk patients that did not achieve ≥ PR after stem cell transplant
- Participant has ≥ grade 2 peripheral neuropathy on clinical examination within 21 days before initiation of protocol therapy
- Creatinine clearance < 30 mL/min (either actual or calculated value), within 21 days of initiation of protocol therapy; the Cockcroft-Gault formula should be used for calculating creatinine clearance values
- Platelet count < 75,000 cells/mm³ at time of screening evaluation; transfusion may not be used to meet platelet eligibility criteria within 7 days of obtaining screening evaluation
- Participants with an absolute neutrophil count (ANC) < 1000 cells/mm³ at time of screening evaluation; growth factors may not be used to meet ANC eligibility criteria within 14 days of obtaining screening evaluation
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- Participants with hemoglobin level < 8.0 g/dL, at time of screening; transfusion may not be used to meet eligibility criteria within 7 days of obtaining screening evaluation
- Bilirubin > 1.5 x institutional upper limit of normal (ULN), within 21 days of initiation of protocol therapy
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]), or alkaline phosphatase > 3 x institutional ULN, within 21 days of initiation of protocol therapy
- Other ongoing or prior anti-myeloma therapy; patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg p.o. once daily [q.d.] or its equivalent) for symptom management and comorbid conditions; doses of corticosteroid should be stable for at least 7 days prior to study treatment)
- Known significant cardiac abnormalities including:
- Congestive heart failure, New York Heart Association (NYHA) class III or IV
- Uncontrolled angina, arrhythmia or hypertension
- Myocardial infarction within the past six months
- Any other uncontrolled or severe cardiovascular condition
- Prior cerebrovascular event with residual neurologic deficit
- Serious, intercurrent illness including, but not limited to, clinically relevant active infection, known active hepatitis B or C viral infection, known human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, or serious co-morbid medical conditions such as chronic restrictive pulmonary disease, and cirrhosis
- Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
- Prior malignancy (within the last 5 years) except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- Known hypersensitivity to acyclovir or similar anti-viral drug
- Known intolerance to steroid therapy
- Contraindication or prior intolerance to thromboembolic prophylaxis with aspirin, warfarin or low-molecular weight heparin
- Participants with known central nervous system (CNS) disease
- Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic composition to dexamethasone, boron or mannitol
- Female participants pregnant or breast-feeding
- Participants who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of the surgery
- Participants with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Maintenance Therapy With Carfilzomib, Pomalidomide and Dexamethasone (CPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In
This phase II trial studies how well carfilzomib, pomalidomide, and dexamethasone work in treating patients with high-risk multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib, pomalidomide, and dexamethasone may work better in treating patients with multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the ≥ complete response (CR) rates with carfilzomib, pomalidomide and dexamethasone (CPd) maintenance.
SECONDARY OBJECTIVES:
- To determine the improved progression free survival (PFS) with CPd maintenance among high-risk patients.
II. To determine the best response rates (very good partial response rate [VGPR], stringent complete response [sCR] rate) with CPd maintenance.
II. To evaluate the safety of the CPd combination as maintenance regimen.
III. To characterize safety in subjects who receive CPd maintenance.
IV. To evaluate the duration of response (DOR).
- To evaluate the overall survival (OS) in high-risk patients.
VI. To evaluate the minimal residual disease (MRD) detection with CPd maintenance.
OUTLINE:
Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 8, and 15, pomalidomide orally (PO) daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
- Conditions
- Plasma Cell Myeloma
- Being tested
- Carfilzomib, Dexamethasone, 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.
CarfilzomibDrug
Also called Kyprolis, PR-171
Given IV
DexamethasoneDrug
Also called Decadron, Dekacort, Dexameth, Hexadrol
Given PO
PomalidomideDrug
Also called 4-Aminothalidomide, Actimid, CC-4047, Imnovid
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Carfilzomib, pomalidomide, dexamethasone | Experimental | Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide PO daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Carfilzomib; Drug: Dexamethasone; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥ Complete response (CR) rates
Completed response (CR) rates will be determined for CPd maintenance.
Measured: Up to 2 years after study start
Secondary outcomes (6)
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from first dose until documented progression or death. A subject who neither progresses nor dies will be censored on the date of his or her last tumor assessments. PFS will be determined by using all enrolled patients in accordance with the intention to treat (ITT) principle.
Measured: From first dose until documented progression or death, assessed at 18 months
Best response on-study
Best response on-study refers to the best response (very good partial response rate [VGPR], stringent complete response [sCR] rate) prior to discontinuation of all study therapy.
Measured: Up to 2 years after study start
Objective response rate (ORR) defined as the proportion of treated subjects who achieve a best response of CR, stringent complete response (sCR), very good partial response (VGPR), or partial response (PR)
The objective response rate (ORR) will be assessed using International Myeloma Working Group (IMWG) criteria.
Measured: Up to 2 years after study start
Duration of response (DOR)
Duration of response (DOR) is the time from first response (PR or better) until a progression event (documented progression or death). Only subjects who ever achieved a response of PR or better will be considered. Subjects who neither progress nor die will be censored on the date of their last tumor assessment.
Measured: From first response (PR or better) until a progression event (documented progression or death), assessed up to 2 years
Overall survival (OS)
Overall survival (OS) is defined as the time from first dose until documented death.
Measured: Up to 2 years after study start
Minimal residual disease (MRD) detection
The achievement of minimal residual disease (MRD) will be evaluated and reported on patients that achieve a complete response. MRD testing will be performed by adaptive clonoSEQ testing.
Measured: Up to 2 years after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start25 Jan 2019
- Primary completion24 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Ajay Nooka, Emory University
- Investigators
- Ajay Nooka, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756896
- Sponsor's protocol ID
- IRB00097882
- Other IDs
- NCI-2017-02052, Winship4101-17, P30CA138292
- Status last verified
- Apr 2025
- First submitted
- 27 Nov 2018
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapy With Carfilzomib, Pomalidomide and Dexamethasone (CPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In
- ClinicalTrials.gov ID
- NCT03756896
- Acronym / sponsor ID
- IRB00097882
- Conditions
- Plasma Cell Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Amgen, National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 24 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Nov 2018 (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.
This phase II trial studies how well carfilzomib, pomalidomide, and dexamethasone work in treating patients with high-risk multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib, pomalidomide, and dexamethasone may work better in treating patients with multiple myeloma.
Detailed description
PRIMARY OBJECTIVE:
- To determine the ≥ complete response (CR) rates with carfilzomib, pomalidomide and dexamethasone (CPd) maintenance.
SECONDARY OBJECTIVES:
- To determine the improved progression free survival (PFS) with CPd maintenance among high-risk patients.
II. To determine the best response rates (very good partial response rate [VGPR], stringent complete response [sCR] rate) with CPd maintenance.
II. To evaluate the safety of the CPd combination as maintenance regimen.
III. To characterize safety in subjects who receive CPd maintenance.
IV. To evaluate the duration of response (DOR).
- To evaluate the overall survival (OS) in high-risk patients.
VI. To evaluate the minimal residual disease (MRD) detection with CPd maintenance.
OUTLINE:
Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 8, and 15, pomalidomide orally (PO) daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carfilzomib, pomalidomide, dexamethasone | Experimental | Drug: Carfilzomib, Drug: Dexamethasone, Drug: PomalidomidePatients receive carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide PO daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must meet the following criteria on screening examination to be eligible to participate in the study; all laboratory assessments should be performed within 28 days of initiation of protocol therapy unless otherwise specified; subject is, in the investigator's opinion, willing and able to comply with the protocol requirements
- Subject has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
- Subject is a transplant-eligible patient that have undergone autologous stem cell transplant (ASCT) within one year of their diagnosis and have achieved ≥ partial response (PR) based on International Myeloma Working Group (IMWG) standard criteria
- Patients with high risk disease defined as
Key exclusion criteria (27 listed)
- Diagnosed with smoldering multiple myeloma (MM), monoclonal gammopathy of undetermined significance, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis or standard risk myeloma or secondary plasma cell leukemia
- High risk patients that did not achieve ≥ PR after stem cell transplant
- Participant has ≥ grade 2 peripheral neuropathy on clinical examination within 21 days before initiation of protocol therapy
- Creatinine clearance < 30 mL/min (either actual or calculated value), within 21 days of initiation of protocol therapy; the Cockcroft-Gault formula should be used for calculating creatinine clearance values
- Platelet count < 75,000 cells/mm³ at time of screening evaluation; transfusion may not be used to meet platelet eligibility criteria within 7 days of obtaining screening evaluation
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 |
|---|---|---|
| CarfilzomibAlso: Kyprolis, PR-171Given IV | Drug | Carfilzomib, pomalidomide, dexamethasone |
| DexamethasoneAlso: Decadron, Dekacort, Dexameth, HexadrolGiven PO | Drug | Carfilzomib, pomalidomide, dexamethasone |
| PomalidomideAlso: 4-Aminothalidomide, Actimid, CC-4047, ImnovidGiven PO | Drug | Carfilzomib, pomalidomide, dexamethasone |
Primary outcome
≥ Complete response (CR) rates
Time frame: Up to 2 years after study start
Completed response (CR) rates will be determined for CPd maintenance.
6 secondary outcomes
Progression-free survival (PFS)
Time frame: From first dose until documented progression or death, assessed at 18 months
Best response on-study
Time frame: Up to 2 years after study start
Objective response rate (ORR) defined as the proportion of treated subjects who achieve a best response of CR, stringent complete response (sCR), very good partial response (VGPR), or partial response (PR)
Time frame: Up to 2 years after study start
Duration of response (DOR)
Time frame: From first response (PR or better) until a progression event (documented progression or death), assessed up to 2 years
Overall survival (OS)
Time frame: Up to 2 years after study start
Minimal residual disease (MRD) detection
Time frame: Up to 2 years after study start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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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.
Ajay Nooka, MD, MPH principal investigator
Emory University
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 Carfilzomib, Dexamethasone and Pomalidomide in people with Plasma Cell Myeloma, run by Emory University 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 10 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
≥ Complete response (CR) rates (time frame: Up to 2 years after study start). 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 30 Apr 2025.