Anlotinib Hydrochloride Capsule Monotherapy and Combination Therapy Relapsed and Refractory Multiple Myeloma

Study Purpose

This is a Single-center, Open-label, Single-arm Exploratory Clinical Study to evaluate the safety and efficacy of Anlotinib Hydrochloride Capsule Monotherapy and Combination Therapy in relapsed or refractory multiple myeloma patient.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. known and volunteered to sign the Informed Consent; 2. Age≥ 18 years. 3. Patients must have previously received a regimen containing immunomodulators and protease inhibitors, and the end-line treatment regimen is refractory or intolerant ( patients recorded as intolerant must discuss and obtain permission from the sponsor 's medical inspector before entering the screening ). Refractory includes primary refractory ( patients did not achieve minimal remission MR or disease progression during treatment ) or secondary refractory ( patients developed disease progression within 60 days after treatment ). 4. Non-hematological toxicity associated with previous treatment occurring prior to the first use of the drug must be reduced to ≤ grade 2, except for peripheral neuropathy, which is specified in article 17 of the exclusion criteria. 5. Liver function met the following criteria : total bilirubin < 2 × upper limit of normal range ( ULN ) ( for patients with Gilbert syndrome, total bilirubin < 3 × ULN ), AST < 2.5 × ULN and ALT < 2.5 × ULN. 6. Renal function meets the following criteria : creatinine clearance ≥ 20 mL / min ( Cockroft-Gault formula ). 7. The ECOG performance status score is 0, 1 or 2. 8. With measurable multiple myeloma, at least one of the following needs to be met : 1. Serum M protein ( SPEP ) ≥ 5 g / L. 2. 24 hour urinary M protein excretion rate ≥ 0.2g ( 200mg ). 3. Serum free light chain ( sFLC ) ≥ 100 mg / L and abnormal free light chain ratio. 9. Blood routine examination met the following criteria ( platelet transfusion was not received within 1 week before the first study, and red blood cell transfusion was not received within 2 weeks before the first study ) : 1. Hemoglobin level ≥ 80g / L. 2. Absolute neutrophil count ( ANC ) ≥ 1000 / mm3 ( 1.0x109 / L ). 3. 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 %, platelet count ≥ 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 or complete abstinence during the use of the research drug and within three months after the last administration of the research drug from the date of signing the informed consent. i. Abstinence : Acceptable when this method is consistent with the preferred and daily lifestyle 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, injectable contraceptives or implantable hormonal contraceptives ; intrauterine device ; barrier contraceptive tools with spermicide ; or the partner received sterilization, combined with the use of at least one barrier contraceptive. b. screening serum pregnancy test results were negative. Note : Fertility refers to all women who have begun their menstrual period, are not in the post-menopausal period and have not undergone surgical sterilization ( e.g. hysterectomy, bilateral tubal ligation, bilateral ovariectomy ). Postmenopause refers to amenorrhea for more than 12 consecutive months for non-specific reasons. Women who are using mechanical contraceptive methods such as oral contraceptives or intrauterine devices should be considered to have fertility. 11. Male subjects ( including those who have undergone vasectomy ) must consent to the use of condoms in their sexual life with women of childbearing age and, from the date of signing the informed consent form, have no plans to conceive a woman during the use of the study drug and within three months after the last administration of the study drug.

Exclusion Criteria:

1. Asymptomatic ( smoking ) multiple myeloma. 2. Plasma cell leukemia. 3. Clarify the combined amyloidosis. 4. Multiple myeloma with central nervous system ( CNS ) invasion. 5. Pregnancy or lactation. 6. First study before medication A. Receiving chemotherapy within 1 week. b. received radiotherapy or immunotherapy within 4 weeks. c. Radioimmunotherapy within 6 weeks. 7. Transplant rejection ( after allogeneic stem cell transplantation ). 8. Life expectancy < 4 months. 9. Oversized surgery within 4 weeks before first study medication. 10. Patients with unstable or active cardiovascular diseases, in line with any of the following : 1. Symptomatic myocardial ischemia ; 2. Uncontrolled and clinically significant conduction abnormalities ( e.g., exclusion of patients with ventricular arrhythmias controlled by antiarrhythmic drugs ; patients with 1 degree atrioventricular ( AV ) block or asymptomatic left anterior bundle branch block / right bundle branch block ( LAFB / RBBB ) were not excluded. 3. New York Heart Association ( NYHA ) definition of congestive heart failure ( CHF ) classification ≥ 3 ; 4. Acute myocardial infarction ( AMI ) occurred within 3 months before the first study. 11. Poorly controlled hypertension ( persistent systolic > 140 mmHg or diastolic > 90 mmHg ). 12. In the first study, there were active infections that were not effectively controlled by drugs within 1 week before treatment. 13. Known HIV positive. 14. A, B, C hepatitis infection active period or known HCV RNA or HBsAg ( HBV surface antigen ) positive. Note : Including HBsAg negative but hepatitis B core ( HBc ) antibody positive, and detectable levels of hepatitis B virus deoxyribonucleic acid ( HBV-DNA ) ( HBV-DNA > 500 IU / ml ). 15. In the 5-year period before the first study, there were previous malignant tumors that needed treatment or had evidence of recurrence [ except for skin basal cell carcinoma and the following carcinoma in situ : squamous cell carcinoma, bladder carcinoma in situ, endometrial carcinoma in situ, cervical carcinoma in situ / atypical hyperplasia, incidental histological findings of prostate cancer ( TNM stage T1a or T1b ) or breast carcinoma in situ ]. 16. There is dysphagia or active gastrointestinal ( GI ) dysfunction that may affect drug absorption. 17. There were ≥ grade 3 peripheral neuropathy and ≥ grade 2 painful neuropathy within 3 weeks before the first study. 18. Active mental disorders or organic diseases considered by researchers to be unsuitable for inclusion. 19. Participated in clinical trials of other drugs within three weeks or five drug half-lives ( T1 / 2 ) prior to the first study. 20. Before treatment received the following treatment, in line with any of the following : 1. Platelet transfusion within 1 week before the first study ; 2. infusion of red blood cells ( RBC ) within 2 weeks before the first study ; 3. The following blood growth factors were used within 2 weeks prior to the first study : granulocyte colony-stimulating factor ( G-CSF ), granulocyte-macrophage colony-stimulating factor ( GM-CSF ), erythropoietin ( EPO ), megakaryocyte growth factor, and / or platelet-stimulating factor. 21. Intolerance or contraindications to glucocorticoid therapy are known. 22. Anlotinib has been used.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05549973
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institute of Hematology & Blood Diseases Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gang An
Principal Investigator Affiliation chief physician
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

This study is an exploratory study, which is divided into two parts. The first part uses BOIN design to explore the phase II recommended dose and safety of anlotinib monotherapy or combination regimen. The second part explored the efficacy and safety of anlotinib in the treatment of RRMM with phase II recommended dose monotherapy and combination regimen. Set up two treatment options, in which A program for monotherapy : Anlotinib monotherapy + dexamethasone ; regimen B is a combination therapy regimen : anlotinib combined with pomalidomide or dalattoumab + dexamethasone.

Arms & Interventions

Arms

Experimental: Anlotinib Hydrochloride Capsule

Anlotinib Hydrochloride Capsule, 21 days as a treatment cycle.

Interventions

Drug: - Anlotinib Hydrochloride Capsule

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

InstituteHBDH, Tianjin, Tianjin, China

Status

Recruiting

Address

InstituteHBDH

Tianjin, Tianjin, 300000

Site Contact

Gang An

angang@ihcams.ac.cn

+008613502181109