Overview

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

Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Dexamethasone
Pomalidomide
Criteria
Inclusion Criteria:

1. Age from 20 to 80 years-old

2. Relapse or progression of multiple myeloma after treatment of
carfilzomib/lenalidomide/dexamethasone (KRd)

3. 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

4. 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

5. 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

6. Eastern Cooperative Oncology Group performance scale 0~2

7. Life expectancy longer than 3 months

8. Written informed consent

9. Prior therapy with bortezomib

10. Patients who meet the following criteria

- If a woman of childbearing age

- Women who are willing to use two reliable methods of contraception from 4
weeks prior to administration of study drug, while receiving, temporarily
suspending administration, and 4 weeks after administration of the study
drug.

- Women who have a negative pregnancy test with a minimum sensitivity of 25
IU/mL under medical management

- For men Men who agree to abstain from absolute abstinence or use a proper method
of contraception for the entire duration of treatment and 28 days after the last
dose

- Women of childbearing age Women who have not undergone hysterectomy or
bilateral oophorectomy, women who have not undergone spontaneous menopause
for at least 24 consecutive months (i.e., menstruate at any time during the
last 24 months. However, amenorrhea after chemotherapy does not exclude the
possibility of pregnancy).

- Proper method of contraception

- Very effective way Intrauterine device, hormone therapy (hormone implant,
intrauterine system releasing levonorgestrel, medroxyprogesterone acetate depot
injection, tablets containing progesterone to inhibit ovulation), tubal ligation,
varicose veins in men

- Effective way Men's condom use, diaphragm method, cervical cap

Exclusion Criteria:

1. Grade 3~4 non-hematologic toxicity by carfilzomib during the previous carfilzomib
treatment

2. Prior therapy with pomalidomide

3. Hypersensitivity to thalidomide or lenalidomide

4. Previous refractoriness to carfilzomib according to the IMWG criteria

5. Myocardial infarct within 6 months, heart failure of NYHA Class III~IV, uncontrolled
ventricular arrhythmia, severe coronary arterial obstructive disease

6. Active infection with 14 days prior to treatment

7. Uncontrolled hypertension (Defined as an average systolic blood pressure >= 160 mmHg
or diastolic >= 100 mmHg) or diabetes (HbA1c > 7.0%)

8. HIV, HBV, HCV infection (exception if adequately controlled HBV (undetectable HBV DNA
(< 20 IU/mL or concurrent use of an anti-viral agent), HCV)

9. Severe or uncontrolled medical conditions, laboratory abnormalities, or psychiatric
disorders that may preclude the participation of the study by the physician's
discretion

10. 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

11. 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.

12. Pregnant or nursing women

13. Waldenstroem's macroglobulinemia, POEMS syndrome, or plasma cell leukemia, light chain
amyloidosis

14. LV ejection fraction < 40%