Phase II Study of Carfilzomib, Pomalidomide, and Dexamethasone for Myeloma Patients Who Had Relapsed or Progressed After Carfilzomib, Lenalidomide, and Dexamethasone

NCT05509374 | Unknown Phase 2

• 1 other identifier: SMC-2021-03-147
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  percentage of patients who achieve at least partial response

  assessed for approximately 3 years after administration

Secondary Outcomes (7)

• Complete response rate

  assessed for approximately 3 years after administration

• Progression free survival rate

  assessed for approximately 3 years after administration

• Overall survival

  assessed for approximately 3 years after administration

• Duration of response

  assessed for approximately 3 years after administration

• Time to response

  assessed for approximately 3 years after administration

Study Arms (1)

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.

Drug: Carfilzomib 56 MG [Kyprolis]; Drug: Pomalidomide; Drug: Dexamethasone

Interventions

Carfilzomib 56 MG [Kyprolis] DRUG

Carfilzomib 56 mg/m2 (Day1, 8, 15) (Cycle1 Day1, 20 mg/m2)

A study of carfilzomib, pomalidomide and dexamethasone administration after KRd administration

Pomalidomide DRUG

Pomalidomide 4 mg per os (Day1-21)

A study of carfilzomib, pomalidomide and dexamethasone administration after KRd administration

Dexamethasone DRUG

Dexamethasone 40 mg (D1, 8, 15, 22) (20 mg for patients ≥ 75 years old)

A study of carfilzomib, pomalidomide and dexamethasone administration after KRd administration

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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%

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomib; pomalidomide; Dexamethasone

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Kihyun Kim, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kihyun Kim, 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: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: October 28, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)