Multiple MyelomaPhase 1NCT05549973
Anlotinib Hydrochloride Capsule Monotherapy and Combination Therapy Relapsed and Refractory Multiple Myeloma
A Phase 1 study testing Anlotinib Hydrochloride Capsule in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Anlotinib Hydrochloride Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ).
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- 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 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 ).
- 10.10.Possible pregnant women must meet the following two conditions :
- 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.
- 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.
- 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.
- 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.
Who cannot join
- 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.
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- 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 :
- Symptomatic myocardial ischemia ;
- 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.
- New York Heart Association ( NYHA ) definition of congestive heart failure ( CHF ) classification ≥ 3 ;
- Acute myocardial infarction ( AMI ) occurred within 3 months before the first study.
- Poorly controlled hypertension ( persistent systolic > 140 mmHg or diastolic > 90 mmHg ).
- In the first study, there were active infections that were not effectively controlled by drugs within 1 week before treatment.
- Known HIV positive.
- 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 ).
- 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 ].
- There is dysphagia or active gastrointestinal ( GI ) dysfunction that may affect drug absorption.
- There were ≥ grade 3 peripheral neuropathy and ≥ grade 2 painful neuropathy within 3 weeks before the first study.
- Active mental disorders or organic diseases considered by researchers to be unsuitable for inclusion.
- Participated in clinical trials of other drugs within three weeks or five drug half-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 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.
- Intolerance or contraindications to glucocorticoid therapy are known.
- Anlotinib has been used.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
InstituteHBDH
Tianjin, Tianjin Municipality, 300000
Gang An, +008613502181109, angang@ihcams.ac.cn
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Anlotinib Hydrochloride Capsule
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib Hydrochloride CapsuleDrug
Also called dexamethasone
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib Hydrochloride Capsule | Experimental | Anlotinib Hydrochloride Capsule, 21 days as a treatment cycle. Receives: Drug: Anlotinib Hydrochloride Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate ( ORR )
partial remission ( PR ) + very good partial remission ( VGPR ) + complete remission ( CR ) + strict complete remission ( sCR ).
Measured: 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 survival rate
Measured: 6 months, 9 months, 12 months
TTP
Duration from treatment initiation to disease progression
Measured: From date of randomization until the date of death from any cause,assessed up to 100 months
PFS
Time from the start of treatment to disease progression or death from any cause
Measured: From date of randomization until the date of death from any cause,assessed up to 100 months
DOR
Duration from first observation of at least partial remission ( PR ) to disease progression or death from disease progression, whichever comes first
Measured: From date of randomization until the date of death from any cause,assessed up to 100 months
CBR
ORR + Minimal Remission ( MR )
Measured: From date of randomization until the date of death from any cause,assessed up to 100 months
Clinical Benefit Rate ( CBR ) + Stable Disease DCR
clinical benefit rate ( CBR ) + stable disease ( SD : at least 12 weeks )
Measured: 12 weeks
OS
Time from initiation of treatment to death from any cause
Measured: 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
Minimal residual disease ( MRD ) in patients with CR or sCR
Measured: through study completion, an average of 1 year
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
FISH analysis to diagnose and determine MM subtypes
Measured: 28 days
security of medical
Including hematological toxicity and non-hematological toxicity ; neutropenia, thrombocytopenia, anemia and hand-foot skin reaction, hypertension, hypertriglyceridemia, proteinuria, diarrhea, fatigue, hemoptysis, hypothyroidism, hyponatremia, etc.
Measured: From date of randomization until the date of first documented progression,assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang An, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- Gang An, Principal investigator, chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549973
- Sponsor's protocol ID
- An-MM-001
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05549973
- Acronym / sponsor ID
- An-MM-001
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib Hydrochloride Capsule | Experimental | Drug: Anlotinib Hydrochloride CapsuleAnlotinib Hydrochloride Capsule, 21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (30 listed)
- Asymptomatic ( smoking ) multiple myeloma.
- Plasma cell leukemia.
- Clarify the combined amyloidosis.
- Multiple myeloma with central nervous system ( CNS ) invasion.
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib Hydrochloride CapsuleAlso: dexamethasoneAnlotinib hydrochloride is a muti-target tyrosine kinase inhibitor. | Drug | Anlotinib Hydrochloride Capsule |
Primary outcome
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 ).
10 secondary outcomes
6 months, 9 months, 12 months survival rate ( SR )
Time frame: 6 months, 9 months, 12 months
TTP
Time frame: From date of randomization until the date of death from any cause,assessed up to 100 months
PFS
Time frame: From date of randomization until the date of death from any cause,assessed up to 100 months
DOR
Time frame: From date of randomization until the date of death from any cause,assessed up to 100 months
CBR
Time frame: From date of randomization until the date of death from any cause,assessed up to 100 months
Clinical Benefit Rate ( CBR ) + Stable Disease DCR
Time frame: 12 weeks
OS
Time frame: 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
Time frame: through study completion, an average of 1 year
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
Time frame: 28 days
security of medical
Time frame: From date of randomization until the date of first documented progression,assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang An principal investigator
chief physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anlotinib Hydrochloride Capsule in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang An (008613502181109, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate ( ORR ) (time frame: From date of randomization until the date of first documented progression,assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.