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Carfilzomib, Lenalidomide, and Dexamethasone Re-induction Followed by the 2nd ASCT in Multiple Myeloma Patients Relapsed After the 1st ASCT (KMM1911)

Primary Purpose

Multiple Myeloma

Status

Recruiting

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Lenalidomide maintenance

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
- 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

Exclusion Criteria:

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
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

Sites / Locations

Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm of Lenalidomide maintenance

Arm Description

[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

Outcomes

Primary Outcome Measures

2-year progression free survival rate

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

Secondary Outcome Measures

Complete response rate after KRd #6

percentage of patients who achieve complete response

Complete response rate after ASCT

percentage of patients who achieve complete response

Overall response rate

percentage of patients who achieve at least partial response

Time to response

from the time of written consent to the time of achieving at least partial response

Duration of response

from the time of achieving at least partial response to the time of progressive disease

Overall survival

from the time of written consent to the time of death or last follow-up

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

treatment-emergent adverse events

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

Full Information

NCT ID

NCT05497102

First Posted

July 27, 2022

Last Updated

August 10, 2022

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05497102

Brief Title

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

Acronym

KMM1911

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 8, 2021 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm of Lenalidomide maintenance

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lenalidomide maintenance

Intervention Description

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

Primary Outcome Measure Information:

Title

2-year progression free survival rate

Description

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

Time Frame

2-years after the written consent

Secondary Outcome Measure Information:

Title

Complete response rate after KRd #6

Description

percentage of patients who achieve complete response

Time Frame

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

Title

Complete response rate after ASCT

Description

percentage of patients who achieve complete response

Time Frame

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

Title

Overall response rate

Description

percentage of patients who achieve at least partial response

Time Frame

assessed for approximately 3 years after administration

Title

Time to response

Description

from the time of written consent to the time of achieving at least partial response

Time Frame

assessed for approximately 3 years after administration

Title

Duration of response

Description

from the time of achieving at least partial response to the time of progressive disease

Time Frame

assessed for approximately 3 years after administration

Title

Overall survival

Description

from the time of written consent to the time of death or last follow-up

Time Frame

assessed for approximately 3 years after administration

Title

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

Description

treatment-emergent adverse events

Time Frame

assessed for approximately 2 years during administration

Title

Rate of the successful stem cell harvest

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kihyun Kim, M.D., Ph.D

Phone

82-2-2148-7333

kihyunk.kim@samsung.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kihyun Kim, M.D., Ph.D

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyunju Park

Phone

82-2-2148-7333

hj9734.park@sbri.co.kr

First Name & Middle Initial & Last Name & Degree

Kihyun Kim

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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