Last updated: September 18, 2022
Sponsor: Institute of Hematology & Blood Diseases Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Multiple Myeloma
Lymphoproliferative Disorders
Leukemia
Treatment
N/AClinical Study ID
NCT05549973
An-MM-001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- known and volunteered to sign the Informed Consent;
- Age≥ 18 years
- Patients must have previously received a regimen containing immunomodulators andprotease inhibitors, and the end-line treatment regimen is refractory or intolerant (patients recorded as intolerant must discuss and obtain permission from the sponsor 'smedical inspector before entering the screening ). Refractory includes primaryrefractory ( patients did not achieve minimal remission MR or disease progressionduring treatment ) or secondary refractory ( patients developed disease progressionwithin 60 days after treatment ).
- Non-hematological toxicity associated with previous treatment occurring prior to thefirst use of the drug must be reduced to ≤ grade 2, except for peripheral neuropathy,which is specified in article 17 of the exclusion criteria.
- Liver function met the following criteria : total bilirubin < 2 × upper limit ofnormal range ( ULN ) ( for patients with Gilbert syndrome, total bilirubin < 3 × ULN ), AST < 2.5 × ULN and ALT < 2.5 × ULN.
- Renal function meets the following criteria : creatinine clearance ≥ 20 mL / min (Cockroft-Gault formula ).
- The ECOG performance status score is 0, 1 or 2.
- With measurable multiple myeloma, at least one of the following needs to be met :
- Serum M protein ( SPEP ) ≥ 5 g / L.
- 24 hour urinary M protein excretion rate ≥ 0.2g ( 200mg ).
- Serum free light chain ( sFLC ) ≥ 100 mg / L and abnormal free light chain ratio.
- Blood routine examination met the following criteria ( platelet transfusion was notreceived within 1 week before the first study, and red blood cell transfusion was notreceived within 2 weeks before the first study ) :
- Hemoglobin level ≥ 80g / L.
- Absolute neutrophil count ( ANC ) ≥ 1000 / mm3 ( 1.0x109 / L ).
- If the proportion of plasma cells in bone marrow < 50 %, platelet count ≥ 75,000 / mm3 ( 75x109 / L ) ; such as bone marrow plasma cell ratio ≥ 50 %, plateletcount ≥ 50,000 / mm3 ( 50x109 / L ). 10.10.Possible pregnant women must meet the following two conditions : a. Agrees to use both contraceptive methods approved by the research physician orcomplete abstinence during the use of the research drug and within three months afterthe last administration of the research drug from the date of signing the informedconsent. i. Abstinence : Acceptable when this method is consistent with the preferred and dailylifestyle of the subject. Periodic abstinence ( such as according to the calendar,ovulation, symptoms of body temperature, after ovulation method ) is not accepted. ii. acceptable contraceptive methods include : oral contraceptives, injectablecontraceptives or implantable hormonal contraceptives ; intrauterine device ; barriercontraceptive tools with spermicide ; or the partner received sterilization, combinedwith the use of at least one barrier contraceptive. b. screening serum pregnancy test results were negative. Note : Fertility refers toall women who have begun their menstrual period, are not in the post-menopausal periodand have not undergone surgical sterilization ( e.g. hysterectomy, bilateral tuballigation, bilateral ovariectomy ). Postmenopause refers to amenorrhea for more than 12consecutive months for non-specific reasons. Women who are using mechanicalcontraceptive methods such as oral contraceptives or intrauterine devices should beconsidered to have fertility.
- Male subjects ( including those who have undergone vasectomy ) must consent to the useof condoms in their sexual life with women of childbearing age and, from the date ofsigning the informed consent form, have no plans to conceive a woman during the use of thestudy drug and within three months after the last administration of the study drug.
Exclusion
Exclusion Criteria:
- Asymptomatic ( smoking ) multiple myeloma.
- Plasma cell leukemia.
- Clarify the combined amyloidosis.
- Multiple myeloma with central nervous system ( CNS ) invasion.
- Pregnancy or lactation.
- First study before medication A. Receiving chemotherapy within 1 week. b. receivedradiotherapy or immunotherapy within 4 weeks. c. Radioimmunotherapy within 6 weeks.
- Transplant rejection ( after allogeneic stem cell transplantation ).
- Life expectancy < 4 months.
- Oversized surgery within 4 weeks before first study medication.
- Patients with unstable or active cardiovascular diseases, in line with any of thefollowing :
- Symptomatic myocardial ischemia ;
- Uncontrolled and clinically significant conduction abnormalities ( e.g.,exclusion of patients with ventricular arrhythmias controlled by antiarrhythmicdrugs ; patients with 1 degree atrioventricular ( AV ) block or asymptomatic leftanterior bundle branch block / right bundle branch block ( LAFB / RBBB ) were notexcluded.
- New York Heart Association ( NYHA ) definition of congestive heart failure ( CHF ) classification ≥ 3 ;
- Acute myocardial infarction ( AMI ) occurred within 3 months before the firststudy.
- Poorly controlled hypertension ( persistent systolic > 140 mmHg or diastolic > 90 mmHg ).
- In the first study, there were active infections that were not effectively controlledby drugs within 1 week before treatment.
- Known HIV positive.
- A, B, C hepatitis infection active period or known HCV RNA or HBsAg ( HBV surfaceantigen ) positive. Note : Including HBsAg negative but hepatitis B core ( HBc ) antibody positive, anddetectable levels of hepatitis B virus deoxyribonucleic acid ( HBV-DNA ) ( HBV-DNA > 500 IU / ml ).
- In the 5-year period before the first study, there were previous malignant tumors thatneeded treatment or had evidence of recurrence [ except for skin basal cell carcinomaand the following carcinoma in situ : squamous cell carcinoma, bladder carcinoma insitu, endometrial carcinoma in situ, cervical carcinoma in situ / atypicalhyperplasia, incidental histological findings of prostate cancer ( TNM stage T1a orT1b ) or breast carcinoma in situ ].
- There is dysphagia or active gastrointestinal ( GI ) dysfunction that may affect drugabsorption.
- There were ≥ grade 3 peripheral neuropathy and ≥ grade 2 painful neuropathy within 3weeks before the first study.
- Active mental disorders or organic diseases considered by researchers to be unsuitablefor inclusion.
- Participated in clinical trials of other drugs within three weeks or five drughalf-lives ( T1 / 2 ) prior to the first study.
- Before treatment received the following treatment, in line with any of the following :
- Platelet transfusion within 1 week before the first study ;
- infusion of red blood cells ( RBC ) within 2 weeks before the first study ;
- The following blood growth factors were used within 2 weeks prior to the firststudy : granulocyte colony-stimulating factor ( G-CSF ), granulocyte-macrophagecolony-stimulating factor ( GM-CSF ), erythropoietin ( EPO ), megakaryocytegrowth factor, and / or platelet-stimulating factor.
- Intolerance or contraindications to glucocorticoid therapy are known.
- Anlotinib has been used.
Study Design
Total Participants: 32
Study Start date:
September 01, 2022
Estimated Completion Date:
July 31, 2024
Study Description
Connect with a study center
InstituteHBDH
Tianjin, Tianjin 300000
ChinaActive - Recruiting
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