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

NCT05497102 | Unknown Phase 2

• 1 other identifier: SMC 2019-12-037
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 2-year progression free survival rate

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

  2-years after the written consent

Secondary Outcomes (8)

• Complete response rate after KRd #6

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

• Complete response rate after ASCT

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

• Overall response rate

  assessed for approximately 3 years after administration

• Time to response

  assessed for approximately 3 years after administration

• Duration of response

  assessed for approximately 3 years after administration

Study Arms (1)

Single arm of Lenalidomide maintenance

EXPERIMENTAL

\[KRd #1\~6, Every 4 weeks\] 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

Drug: Lenalidomide maintenance

Interventions

Lenalidomide maintenance DRUG

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

Single arm of Lenalidomide maintenance

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kihyun Kim, M.D., Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kihyun Kim, M.D., Ph.D

CONTACT

82-2-2148-7333; kihyunk.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 11, 2022
• Study Start: November 8, 2021
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2025
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

KR (1)