Single-center, Open-label, Single-arm Exploratory Clinical Trial of Anlotinib Monotherapy and Combination Therapy in Relapsed / Refractory MM Previously Treated With Immunomodulator and Protease Inhibitor Regimens

Institute of Hematology & Blood Diseases Hospital, China1 site in 1 country32 target enrollmentSeptember 2022

ConditionsMultiple Myeloma

InterventionsAnlotinib Hydrochloride Capsule

DrugsAnlotinib Hydrochloride Capsule

Overview

Phase: Phase 1
Intervention: Anlotinib Hydrochloride Capsule
Conditions: Multiple Myeloma
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Enrollment: 32
Locations: 1
Primary Endpoint: Overall response rate ( ORR )
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

September 2022

End Date

July 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Responsible Party

Principal Investigator

Gang An

Deputy Chief Physician

Institute of Hematology & Blood Diseases Hospital, China

Eligibility Criteria

Inclusion Criteria

•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 ).
•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.
•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
•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 ).

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. received radiotherapy 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 the following :

Arms & Interventions

Anlotinib Hydrochloride Capsule

Anlotinib Hydrochloride Capsule, 21 days as a treatment cycle.

Intervention: Anlotinib Hydrochloride Capsule

Outcomes

Primary Outcomes

Overall response rate ( ORR )

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

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

Secondary Outcomes

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)
security of medical(From date of randomization until the date of first documented progression,assessed up to 100 months)
TTP(From date of randomization until the date of death from any cause,assessed up to 100 months)
MRD in CR and sCR patients MRD in CR and sCR patients(through study completion, an average of 1 year)
6 months, 9 months, 12 months survival rate ( SR )(6 months, 9 months, 12 months)
CBR(From date of randomization until the date of death from any cause,assessed up to 100 months)
OS(From date of randomization until the date of death from any cause,assessed up to 100 months)
Clinical Benefit Rate ( CBR ) + Stable Disease DCR(12 weeks)
The influence of risk factors stratification based on fluorescence in situ hybridization ( FISH ) on clinical efficacy, including del 13, del 17p13, t ( 4 ; 14 ), t ( 14 ; 16 ), 1q21 amplification(28 days)