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Trial Title:
Carfilzomib, Lenalidomide, and Dexamethasone Re-induction Followed by the 2nd ASCT in Multiple Myeloma Patients Relapsed After the 1st ASCT
NCT ID:
NCT05497102
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lenalidomide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lenalidomide maintenance
Description:
Lenalidomide maintenance after carfilzomib, lenalidomide, and dexamethasone re-induction
followed by the 2nd ASCT.
Arm group label:
Single arm of Lenalidomide maintenance
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 20~70
2. Progressive disease after 1st ASCT
3. Duration of response after 1st ASCT > 12 months
4. 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)
5. 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
6. Eastern Cooperative Oncology Group performance scale 0~2
7. Survival expectancy > 3 months
8. Adequately controlled hepatitis B(HBV) & hepatitis C(HCV)
9. Written informed consent
10. Optimal contraceptions
Exclusion Criteria:
1. Prior refractoriness or intolerance to carfilzomib
2. Prior refractoriness or intolerance to lenalidomide/dexamethasone
3. Any treatment after progressive disease after 1st ASCT. High-dose dexamethasone or
palliative radiation is permitted.
4. Waldenstroem's macroglobulinemia, POEMS syndrome, or plasma cell leukemia
5. Pregnant or nursing lactating women
6. Myocardial infarct within 6 months, heart failure of New York Heart
Association(NYHA) Class III~IV, uncontrolled ventricular arrhythmia, severe coronary
arterial obstructive disease
7. Uncontrolled hypertension (Defined as an average systolic blood pressure >= 160 mmHg
or diastolic >= 100 mmHg) or diabetes
8. Grade 3~4 neuropathy
9. HIV infection
10. Severe or uncontrolled medical conditions, laboratory abnormalities, or psychiatric
disorders that may preclude the participation of the study by the physician's
discretion
11. 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
12. 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
Gender:
All
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyunju Park
Phone:
82-2-2148-7333
Email:
hj9734.park@sbri.co.kr
Investigator:
Last name:
Kihyun Kim
Email:
Principal Investigator
Start date:
November 8, 2021
Completion date:
December 2025
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05497102