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

NCT05549973 | Unknown Phase 1

• 1 other identifier: An-MM-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall response rate ( ORR )

  partial remission ( PR ) + very good partial remission ( VGPR ) + complete remission ( CR ) + strict complete remission ( sCR ).

  From date of randomization until the date of first documented progression,assessed up to 100 months

Secondary Outcomes (10)

• 6 months, 9 months, 12 months survival rate ( SR )

  6 months, 9 months, 12 months

• TTP

  From date of randomization until the date of death from any cause,assessed up to 100 months

• PFS

  From date of randomization until the date of death from any cause,assessed up to 100 months

• DOR

  From date of randomization until the date of death from any cause,assessed up to 100 months

• CBR

  From date of randomization until the date of death from any cause,assessed up to 100 months

Study Arms (1)

Anlotinib Hydrochloride Capsule

EXPERIMENTAL

Anlotinib Hydrochloride Capsule, 21 days as a treatment cycle.

Drug: Anlotinib Hydrochloride Capsule

Interventions

Anlotinib Hydrochloride Capsule DRUG

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Also known as: dexamethasone

Anlotinib Hydrochloride Capsule

Eligibility Criteria

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

You may qualify if:

• known and volunteered to sign the Informed Consent;
• Age≥ 18 years
• 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 ).

You may not qualify if:

• 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.
• 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.
• 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 not received within 1 week before the first study, and red blood cell transfusion was not received 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 %, platelet count ≥ 50,000 / mm3 ( 50x109 / L ).
• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

InstituteHBDH

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

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

• Gang An

  chief physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang An

CONTACT

008613502181109; angang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 22, 2022
• Study Start: September 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

CN (1)