Multiple MyelomaPhase 2KMM2002NCT05509374
Phase II Study of Carfilzomib, Pomalidomide, and Dexamethasone for Myeloma Patients Who Had Relapsed or Progressed After Carfilzomib, Lenalidomide, and Dexamethasone
A Phase 2 study testing Carfilzomib 56 MG [Kyprolis], Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the evaluate the efficacy and safety of administering a combination of carfilzomib, pomalidomide, and dexamethasone in patients with relapsed or advanced multiple myeloma after carfilzomib, lenalidomide, and dexamethasone therapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Carfilzomib 56 MG [Kyprolis], Pomalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2021to 30 Jun 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 20 to 80 years-old
- Relapse or progression of multiple myeloma after treatment of carfilzomib/lenalidomide/dexamethasone (KRd)
- KRd treatment 12 cycles or more and lenalidomide maintenance for at least 6 months or KRd 4-6 cycles followed by ASCT and lenalidomide maintenance for at least 6 months
- Measurable disease
- Serum M-protein ≥ 1 g/dL (10 g/L)
- Urine M-protein ≥ 200 mg/24 hr
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- Serum FLC assay: difference of FLC ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal (KL ratio < 0.26 or > 1.65) if Serum EP or urine EP is not measurable
- Adequate organ functions
- Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L
- Platelets ≥ 50 x 109/L (≥ 30 x 109/L if myeloma involvement is > 50% in the bone marrow)
- Hemoglobin ≥ 8.0 g/dL
- Creatinine clearance ≥ 30 mL/minute or Serum Cr <3.0 g/dL
- Serum Bilirubin ≤ 1.5 x ULN
- AST and ALT ≤ 3 x ULN
- Eastern Cooperative Oncology Group performance scale 0~2
- Life expectancy longer than 3 months
- Written informed consent
- Prior therapy with bortezomib
- Patients who meet the following criteria
- If a woman of childbearing age
- Women who are willing to use two reliable methods of contraception from 4 weeks prior to administration of study drug, while receiving, temporarily suspending administration, and 4 weeks after administration of the study drug.
- Women who have a negative pregnancy test with a minimum sensitivity of 25 IU/mL under medical management
- For men Men who agree to abstain from absolute abstinence or use a proper method of contraception for the entire duration of treatment and 28 days after the last dose
- Women of childbearing age Women who have not undergone hysterectomy or bilateral oophorectomy, women who have not undergone spontaneous menopause for at least 24 consecutive months (i.e., menstruate at any time during the last 24 months. However, amenorrhea after chemotherapy does not exclude the possibility of pregnancy).
- Proper method of contraception
- Very effective way Intrauterine device, hormone therapy (hormone implant, intrauterine system releasing levonorgestrel, medroxyprogesterone acetate depot injection, tablets containing progesterone to inhibit ovulation), tubal ligation, varicose veins in men
- Effective way Men's condom use, diaphragm method, cervical cap
Who cannot join
- Grade 3~4 non-hematologic toxicity by carfilzomib during the previous carfilzomib treatment
- Prior therapy with pomalidomide
- Hypersensitivity to thalidomide or lenalidomide
- Previous refractoriness to carfilzomib according to the IMWG criteria
- Myocardial infarct within 6 months, heart failure of NYHA Class III~IV, uncontrolled ventricular arrhythmia, severe coronary arterial obstructive disease
- Active infection with 14 days prior to treatment
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- Uncontrolled hypertension (Defined as an average systolic blood pressure >= 160 mmHg or diastolic >= 100 mmHg) or diabetes (HbA1c > 7.0%)
- HIV, HBV, HCV infection (exception if adequately controlled HBV (undetectable HBV DNA (< 20 IU/mL or concurrent use of an anti-viral agent), HCV)
- Severe or uncontrolled medical conditions, laboratory abnormalities, or psychiatric disorders that may preclude the participation of the study by the physician's discretion
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- Diagnosis of other malignant disease other than myeloma within 5 year. Exceptions are properly treated non-melanomatous skin cancers, cervical intraepithelial neoplasia, prostate cancer that do not require treatment, or properly excised well-differentiated thyroid cancers.
- Pregnant or nursing women
- Waldenstroem's macroglobulinemia, POEMS syndrome, or plasma cell leukemia, light chain amyloidosis
- LV ejection fraction < 40%
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Bobae Lee, 82-2-2148-7690, bb.lee@sbri.co.kr
Kihyun Kim, Ph.D
About this study
Official title: Phase II, Single-arm Trial of Carfilzomib, Pomalidomide, and Dexamethasone for Myeloma Patients Who Had Relapsed or Progressed After Carfilzomib, Lenalidomide, and Dexamethasone
The purpose of this study is to evaluate the evaluate the efficacy and safety of administering a combination of carfilzomib, pomalidomide, and dexamethasone in patients with relapsed or advanced multiple myeloma after carfilzomib, lenalidomide, and dexamethasone therapy.
Read the detailed description
This study is a phase 2 study in which patients with RRMM under 80 years of age who have been treated with lenalidomide monotherapy for at least 6 months after KRd combination therapy will receive carfilzomib, pomalidomide, and dexamethasone combination therapy.
A total of 33 participants are recruited.
KPd will be administered until progressive disease or unacceptable toxicities.
Participants who discontinued treatment will be followed up for disease status and survival at 2-month intervals.
Responses are assessed using the International Myeloma Working Group (IMWG) response criteria and the safety profile is described using NCI-CTCAE v5.0.
- Conditions
- Multiple Myeloma
- Being tested
- Carfilzomib 56 MG [Kyprolis], Pomalidomide, 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.
Carfilzomib 56 MG [Kyprolis]Drug
Carfilzomib 56 mg/m2 (Day1, 8, 15) (Cycle1 Day1, 20 mg/m2)
PomalidomideDrug
Pomalidomide 4 mg per os (Day1-21)
DexamethasoneDrug
Dexamethasone 40 mg (D1, 8, 15, 22) (20 mg for patients ≥ 75 years old)
| Study group | Role | What they receive |
|---|---|---|
| A study of carfilzomib, pomalidomide and dexamethasone administration after KRd administration | Experimental | Patients with RRMM who progressed after receiving lenalidomide monotherapy for at least 6 months after administration of KRd will receive KPD therapy every 4 weeks until disease progression. Receives: Drug: Carfilzomib 56 MG [Kyprolis]; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
percentage of patients who achieve at least partial response
Measured: assessed for approximately 3 years after administration
Secondary outcomes (7)
Complete response rate
percentage of patients who achieve complete response
Measured: assessed for approximately 3 years after administration
Progression free survival rate
percentage of patients who are disease free or alive
Measured: assessed for approximately 3 years after administration
Overall survival
from the time of written consent to the time of death or last follow-up
Measured: assessed for approximately 3 years after administration
Duration of response
from the time of achieving at least partial response to the time of progressive disease
Measured: assessed for approximately 3 years after administration
Time to response
from the time of written consent to the time of achieving at least partial response
Measured: assessed for approximately 3 years after administration
Incidence of treatment-emergent adverse events
Safety profiles of carfilzomib, pomalidomide, and dexamethasone for myeloma patients who had relapsed or progressed
Measured: assessed for approximately 3 years after administration
Minimal residual disease negativity
The specimen is bone marrow aspirate, and it should be free of clonal plasma cells by examination by the NGF (next-generation flow) method. At this time, the test should be performed according to the EuroFlow standard operation procedure for MRD detection in MM, and the minimum sensitivity should be10 to the 5th power or higher.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start28 Oct 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
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 Samsung Medical CenterThe 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kihyun Kim, Samsung Medical Center
- Investigators
- Kihyun Kim, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509374
- Sponsor's protocol ID
- SMC-2021-03-147
- Acronym
- KMM2002
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single-arm Trial of Carfilzomib, Pomalidomide, and Dexamethasone for Myeloma Patients Who Had Relapsed or Progressed After Carfilzomib, Lenalidomide, and Dexamethasone
- ClinicalTrials.gov ID
- NCT05509374
- Acronym / sponsor ID
- KMM2002 / SMC-2021-03-147
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Aug 2022 (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 purpose of this study is to evaluate the evaluate the efficacy and safety of administering a combination of carfilzomib, pomalidomide, and dexamethasone in patients with relapsed or advanced multiple myeloma after carfilzomib, lenalidomide, and dexamethasone therapy.
Detailed description
This study is a phase 2 study in which patients with RRMM under 80 years of age who have been treated with lenalidomide monotherapy for at least 6 months after KRd combination therapy will receive carfilzomib, pomalidomide, and dexamethasone combination therapy.
A total of 33 participants are recruited.
KPd will be administered until progressive disease or unacceptable toxicities.
Participants who discontinued treatment will be followed up for disease status and survival at 2-month intervals.
Responses are assessed using the International Myeloma Working Group (IMWG) response criteria and the safety profile is described using NCI-CTCAE v5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A study of carfilzomib, pomalidomide and dexamethasone administration after KRd administration | Experimental | Drug: Carfilzomib 56 MG [Kyprolis], Drug: Pomalidomide, Drug: DexamethasonePatients with RRMM who progressed after receiving lenalidomide monotherapy for at least 6 months after administration of KRd will receive KPD therapy every 4 weeks until disease progression. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Age from 20 to 80 years-old
- Relapse or progression of multiple myeloma after treatment of carfilzomib/lenalidomide/dexamethasone (KRd)
- KRd treatment 12 cycles or more and lenalidomide maintenance for at least 6 months or KRd 4-6 cycles followed by ASCT and lenalidomide maintenance for at least 6 months
- Measurable disease
- Adequate organ functions
Key exclusion criteria (14 listed)
- Grade 3~4 non-hematologic toxicity by carfilzomib during the previous carfilzomib treatment
- Prior therapy with pomalidomide
- Hypersensitivity to thalidomide or lenalidomide
- Previous refractoriness to carfilzomib according to the IMWG criteria
- Myocardial infarct within 6 months, heart failure of NYHA Class III~IV, uncontrolled ventricular arrhythmia, severe coronary arterial obstructive disease
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 |
|---|---|---|
| Carfilzomib 56 MG [Kyprolis]Carfilzomib 56 mg/m2 (Day1, 8, 15) (Cycle1 Day1, 20 mg/m2) | Drug | A study of carfilzomib, pomalidomide and dexamethasone administration after KRd administration |
| PomalidomidePomalidomide 4 mg per os (Day1-21) | Drug | A study of carfilzomib, pomalidomide and dexamethasone administration after KRd administration |
| DexamethasoneDexamethasone 40 mg (D1, 8, 15, 22) (20 mg for patients ≥ 75 years old) | Drug | A study of carfilzomib, pomalidomide and dexamethasone administration after KRd administration |
Primary outcome
Overall response rate
Time frame: assessed for approximately 3 years after administration
percentage of patients who achieve at least partial response
7 secondary outcomes
Complete response rate
Time frame: assessed for approximately 3 years after administration
Progression free survival rate
Time frame: assessed for approximately 3 years after administration
Overall survival
Time frame: assessed for approximately 3 years after administration
Duration of response
Time frame: assessed for approximately 3 years after administration
Time to response
Time frame: assessed for approximately 3 years after administration
Incidence of treatment-emergent adverse events
Time frame: assessed for approximately 3 years after administration
Minimal residual disease negativity
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- 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.
Kihyun Kim, Ph.D principal investigator
Samsung Medical Center
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 56 MG [Kyprolis], Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Samsung Medical Center at 1 site in South Korea.
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 27 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kihyun Kim, Ph.D (82-2-2148-7333, kihyunk.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: assessed for approximately 3 years after administration). 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 22 Aug 2022.