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Multiple MyelomaPhase 2KMM1911NCT05497102

Carfilzomib, Lenalidomide, and Dexamethasone Re-induction Followed by the 2nd ASCT in Multiple Myeloma Patients Relapsed After the 1st ASCT

A Phase 2 study testing Lenalidomide maintenance in people with Multiple Myeloma, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of salvage treatment with carfilzomib/lenalidomide/dexamethasone (KRD) followed by 2nd autologous stem cell transplantation (ASCT) and lenalidomide maintenance in patients with relapsed myeloma after 1st ASCT. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Lenalidomide maintenance
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteSouth Korea
Study dates
8 Nov 2021to Dec 2025
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 20~70
  • Progressive disease after 1st ASCT
  • Duration of response after 1st ASCT > 12 months
  • Measurable disease (+)
  • Serum M-protein ≥ 1 g/dL
  • Urine M-protein ≥ 200 mg/24 hr
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  • Serum Free Light Chain(FLC) assay: involved FLC level ≥10 mg/dL (serum Free Light Chain ratio is abnormal)
  • Adequate organ function for induction \& ASCT
  • 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
  • Serum Bilirubin ≤ 1.5 x upper limit of normal
  • Aspartate aminotransferase(AST) and Alanine aminotransferase(ALT) ≤ 3 x upper limit of normal
  • Eastern Cooperative Oncology Group performance scale 0~2
  • Survival expectancy > 3 months
  • Adequately controlled hepatitis B(HBV) \& hepatitis C(HCV)
  • Written informed consent
  • Optimal contraceptions

Who cannot join

  • Prior refractoriness or intolerance to carfilzomib
  • Prior refractoriness or intolerance to lenalidomide/dexamethasone
  • Any treatment after progressive disease after 1st ASCT. High-dose dexamethasone or palliative radiation is permitted.
  • Waldenstroem's macroglobulinemia, POEMS syndrome, or plasma cell leukemia
  • Pregnant or nursing lactating women
  • Myocardial infarct within 6 months, heart failure of New York Heart Association(NYHA) Class III~IV, uncontrolled ventricular arrhythmia, severe coronary arterial obstructive disease
Show all 12Show fewer
  • Uncontrolled hypertension (Defined as an average systolic blood pressure >= 160 mmHg or diastolic >= 100 mmHg) or diabetes
  • Grade 3~4 neuropathy
  • HIV infection
  • 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

Trial locations and contacts

1 site in 1 country.

Kihyun Kim, M.D., Ph.D contact

82-2-2148-7333

kihyunk.kim@samsung.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul

    Hyunju Park, 82-2-2148-7333, hj9734.park@sbri.co.kr

    Kihyun Kim

    Recruiting

Other trials in South Korea

About this study

Official title: Phase II, Single-arm Trial of Carfilzomib, Lenalidomide, and Dexamethasone Re-induction Followed by the 2nd ASCT in Multiple Myeloma Patients Relapsed After the 1st ASCT

The purpose of this study is to evaluate the efficacy and safety of salvage treatment with carfilzomib/lenalidomide/dexamethasone (KRD) followed by 2nd autologous stem cell transplantation (ASCT) and lenalidomide maintenance in patients with relapsed myeloma after 1st ASCT.

Read the detailed description

This is a single-arm phase II study to assess the efficacy and safety of KRD followed by 2nd ASCT - lenalidomide maintenance for 18 months in patients with relapsed multiple myeloma after 1st ASCT who are 70 years of age or younger. A total of 58 participants will be recruited. As a re-induction therapy 6 cycles of KRD (K, 27mg/m2, D1,2,8,9,15,16; R, 25 mg, D1-21; D, 40mg weekly, every 28 days) will be administered. If a patient achieves at least partial response, 2nd ASCT + lenalidomide 10mg for 18 months will be proceeded. Study will be continued until disease progression, unacceptable toxicity, or completion of pre-planned schedule. Response will be assessed using the International Myeloma Working Group(IMWG) response criteria and the safety profiles will be described using the NCI-CTCAE v5.0. Participants who discontinue therapy will be followed every 3 months for 3 years if they are on subsequent treatment, disease-free or dead.

Being tested
Lenalidomide maintenance
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lenalidomide maintenanceDrug

    Lenalidomide maintenance after carfilzomib, lenalidomide, and dexamethasone re-induction followed by the 2nd ASCT.

Study groups in NCT05497102
Study groupRoleWhat they receive
Single arm of Lenalidomide maintenanceExperimental[KRd #1~6, Every 4 weeks] D1, 2, 8, 9, 15,16 Carfilzomib 20mg/m2 + 5% dextrose in water 50 mL over 10 mins (From Cycle1Day8 27mg/m2) D1 - 21 Lenalidomide 25mg P.O. D1, 8, 15, 22 Dexamethasone 40mg IV or PO [Autologous stem cell transplantation phase] [Lenalidomide maintenance phase, Every 4 weeks] D1-28 Lenalidomide 10 mg
Receives: Drug: Lenalidomide maintenance

What is being measured

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

  1. 2-year progression free survival rate

    percentage of patients who are disease free or alive at 2-years

    Measured: 2-years after the written consent

Secondary outcomes (8)

  1. Complete response rate after KRd #6

    percentage of patients who achieve complete response

    Measured: total 6 cycles (each cycle is 28 days) of induction therapy

  2. Complete response rate after ASCT

    percentage of patients who achieve complete response

    Measured: at the time of 2nd ASCT (within 60 days after ASCT)

  3. Overall response rate

    percentage of patients who achieve at least partial response

    Measured: assessed for approximately 3 years after administration

  4. 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

  5. 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

  6. 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

  7. Safety of KRd induction therapy, 2nd ASCT, and lenalidomide maintenance therapy

    treatment-emergent adverse events

    Measured: assessed for approximately 2 years during administration

  8. Rate of the successful stem cell harvest

    percentage of patients who collected cluster of differentiation(CD34+) hematopoietic stem cells > 2 x 10^6 cells/kg

    Measured: total 6 cycles (each cycle is 28 days) of induction therapy

Timeline

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

  1. First posted11 Aug 2022
  2. Study start8 Nov 2021
  3. Primary completionMay 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497102
Sponsor's protocol ID
SMC 2019-12-037
Acronym
KMM1911
Status last verified
Aug 2022
First submitted
27 Jul 2022
Last updated
12 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide maintenance 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 19 inclusion and 12 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 12 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, M.D., 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?

2-year progression free survival rate (time frame: 2-years after the written consent). 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 NCT05497102.

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 12 Aug 2022.

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