A Phase 2 Study of Daratumumab in Combination with Lenalidomide, Bortezomib and Dexamethasone in Elderly Newly Diagnosed Multiple Myeloma Patients eligible for ASCT
- Conditions
- Neoplasms
- Registration Number
- KCT0006549
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 26
1. A newly diagnosed from 65 to 69 aged multiple myeloma patient capable of ASCT.
2. A person who has not been previously treated with multiple myeloma (However, patients who have been previously treated with SMM and MGUS can be selected.)
3. Patients diagnosed with multiple myeloma in accordance with the diagnostic standards below
1) More than 10% of monoclonal cell in bone marrow or a type of metamorphosis identified by biopsy
2) Patients who have multiple myeloma that can be evaluated and fall under at least one of the following conditions:
- Serum M-protein =0.5 g/dL or urine M-protein = 200 mg/24h, serum FLC assay ratio: (involved/uninvolved = 100)
- FLC multiple myeloma: Serum FLC (sFLC) =10 mg/dL and abnormal serum kappa/lambda FLC ratio
- Oligo or non-secretory multiple myeloma: plasmacytoma is identified or abnormal FLC ratio (n.v.: 0.26-1.65) in clinical examination or applicable radiography.
4. Multiple myeloma patients with symptoms based on CRAB criteria
- Calcium elevation > 11mg/dL or > 1mg/dL higher than ULN
- Renal insufficiency (Creatinine clearance<40mg/min or serum creatinine > 2mg/dL
- Anemia (Hb <10g/dL or 2g/dL< normal)
- Bone disease ( = 1 lytic lesions or skeletal radiography, CT or PET-CT)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
6. If the patient's laboratory blood test is abnormal at the time of screening as follows, participation is determined by the medical team's judgment.
- ANC < 1 x 10^9/L
- Platelet < 80 x 10^9/L
- Red blood cells < 8 g/dl.
- AST and/or ALT < 5 x the upper limit of normal (ULN).
- Bilirubin < 1.5x ULN
- Calculated or measured creatinine clearance: < 30mL/minute
7. Patients who meet the following criteria:
* For women of childbearing age
- Women who agree to use effective contraception during clinical trial and for 28 days after completion of administration
- Women with a negative result in a minimum sensitivity of 25 IU/mL pregnancy tests under medical care
* For women of non-childbearing age
- Women who have undergone hysterectomy or bilateral oophorectomy.
- Women who have been menopause for at least 24 consecutive months (i.e., have not been menstruating continuously in the past 24 months. However, if amenorrhea after chemotherapy does not rule out pregnancy.)
* * For men
- Men who agree to use effective contraception during clinical trial and for 28 days after completion of administration
- Men who agree not to donate semen during clinical trial and for 28 days after completion of administration
* Appropriate contraception
- A very effective method
Intrauterine devices, hormone therapy (hormone implants, intrauterine systems that release levonorgestrel, medroxyprogesterone acetate depot injections, containing ovulation-suppressing progesterone), tubal ligation, vasectomy.
- Effective methods
Men's use of condoms, diaphragm, cervical caps.
8. A person who can voluntarily give written consent before conducting clinical research which is not part of a normal medical service, and who can understand that the patient can withdraw his consent at any time without infringing on future treatment.
1. All subjects not suitable for ASCT.
A. COPD patients (if FEV1 is less than 50% normal)
B. A person who is being treated for persistent asthma.
2. Recurrence, irresponsive mutiple myeloma patients, and a person who has been previously treated with multiple myeloma are excluded (However, Radiotherapy, Bisphosphonate, short-term steroid use within 4 days corresponding to 40 mg/day dexamethasone is permitted.)
3. plasma cell leukemia (>2.0×109/L circulating plasma cells by standard differential), Waldenstroms macroglobulinemia, POEMS syndrome, or a patient diagnosed with amyloidosis.
4. Patients with allergies to drugs (Daratumumab, Bortezomib, Lenalidomide) who has been diagnosed and treated with SMM and MGUS.
5. Pregnant or lactating women
6. Clinically significant heart disease
- Uncontrolled heart disease, unstable heart disease despite treatment that affects cardiac function, myocardial infarction within 6 months prior to the start of the study (e.g., unstable angina, heart failure of NYHA III-IV)
- Arrhythmia (grade 2 or higher based on CVCAE version 5) or clinically significant ECG abnormaility.
7. A history of significant neurological or mental illness, including dementia or seizures.
8. Uncontrolled infectious diseases
- People with antibiotics or infiltrating lung diseases and acute active infections
- It is accompanied by acute activity infections that require antibiotics, anti-viral drugs (excluding hepatitis B antiviral drugs) or anti-fungal drugs within 14 days of clinical research
- Patients with HIV serum positive, hepatitis C and/or hepatitis B (HBsAg (+) or anti-HBc (+) who are undergoing anti-virus therapy for hepatitis B infection, HBsAg (+) or anti-HBc (+) but DNA (-) patients are acceptable.
9. Patients with malignant tumor history other than target diseases except in the following cases
(If at least 5 years treatment has not been carried out for the tumor, or disease-free condition, at least one year has elapsed since the successful treatment of carcinoma in situ of uterine cervix or complete removal of basal/squamous cell carcinoma)
10. Patients with terminal nephropathy requiring hemodialysis or peritoneal dialysis and patients with liver failure (Child-Pugh C) and cirrhosis
11. Patients with genetic problems such as Galactose intolerance, Lapplactase deficiency or glucose-galactose malabsorption
12. Those who take supplementary care and related medications that require attention to the use of medications
13. Patients with an overactive history of Lenalidomide and Bortezomib
14. Male patients who do not agree with appropriate contraceptive methods
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Very Good Partial Rate(VGPR)
- Secondary Outcome Measures
Name Time Method Percentage of patients with Minimal Residual Disease(MRD);Duration of Response, DoR;Overall Response Rate and Complete Response rate;Time to progression, TTP;Progression free survival;Overall survival, OS;Safety profile and toxicity profile