A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma

A Phase 2 study testing ACE-011 in people with Multiple Myeloma, run by Celgene at 2 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma. 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?: ACE-011
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 2 sitesRussia
Study dates: 1 Sep 2008to 1 Aug 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patient at least 18 years of age with stage II or III multiple myeloma
One or more lytic bone lesions
If currently receiving bisphosphonate therapy, have been on a stable dose for ≥ 2 months before dosing day 1 or must not have received bisphosphonates within 2 months of dosing day 1
If patient has undergone previous autologous or allogenic hematopoietic stem cell transplantation (HSCT), they must be stable (in the opinion of the investigator) and be a minimum of 6 months since HSCT
Has planned HSCT for the duration of the study
Has moles or lesions that are currently undiagnosed, but are suspect for malignancy
Has an underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions, such as a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, Paget's disease of the bone, or osteomalacia; patients with a diagnosis of osteoporosis prior to multiple myeloma diagnosis are eligible to participate.

Who cannot join

Known underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions
History of polyneuropathy ≥ grade 3
Patients with plasma cell leukemia
Planned stem cell transplant (HSCT) or radiation for the duration of the study
Skeletal related event within 2 weeks of study enrollment
Has received erythropoiesis-stimulating agents (ESAs) within the last 21 days or is planned to receive ESAs during the course of the study

Show all 10Show fewer

Has received anti-myeloma therapy within the last 21 days
Is scheduled to receive local radiation to bone during the course of the study
Has taken estrogen, androgen, anabolic steroids, calcitonin or other bone-active drugs within 4 months of study enrollment
Woman of childbearing potential (not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months)

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

Investigative Site
Moscow
Investigative Site
Saint Petersburg

Other trials in Russia

About this study

Official title: A Phase 2a, Multi-Center, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ACE-011 (hActRIIA-IgG1) in Patients With Osteolytic Lesions of Multiple Myeloma

Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.

Conditions: Multiple Myeloma
Being tested: ACE-011, Placebo
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACE-011Biological
Also called hActRIIA-IgG1
ACE-011 given by the subcutaneous route of administration monthly for 4 doses.
PlaceboBiological
Placebo given by the subcutaneous route of administration monthly for 4 doses.

Study groups in NCT00747123
Study group	Role	What they receive
Placebo	Placebo comparator	Subcutaneous injection on days 1, 29, 57 and 85. Receives: Biological: Placebo
ACE-011 0.1 mg/kg	Experimental	Subcutaneous injection of ACE-011 0.1 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). Receives: Biological: ACE-011
ACE-011 0.3 mg/kg	Experimental	Subcutaneous injection of ACE-011 0.3 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). Receives: Biological: ACE-011
ACE-011 0.5 mg/kg	Experimental	Subcutaneous injection of ACE-011 0.5 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85). Receives: Biological: ACE-011

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A treatment emergent adverse event (TEAE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causality assessment. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported.
Measured: From first dose to termination visit on Day 169
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug
A treatment emergent adverse event (TEAE) related to study drug was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, that was determined to be related to the study drug. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. Treatment emergent adverse events were assessed by the investigator as possibly, probably, or definitely related to the study drug.
Measured: From first dose to termination visit on Day 169
Number of Participants With Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that at any dose (including overdose) that was fatal, was life threatening, required or prolonged inpatient hospitalization, resulted in permanent or significant disability/incapacity, or was a congenital anomaly/birth defect. The number of participants with at least one serious adverse event are reported.
Measured: From first dose up to termination visit on Day 169
Change From Baseline in Hemoglobin
Summary of the change from baseline in hemoglobin (g/dL) by the pre-specified timepoints. Baseline was defined as the last measurement prior to dosing. Data were summarized for all treated participants who had at least 1 postdosing measurement.
Measured: Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169
Number of Participants With Electrocardiogram Abnormalities
The number of participants with at least one clinically significant postbaseline electrocardiogram abnormality. The abnormalities included left ventricular hypertrophy, atrial fibrillation, sinus bradycardia, sinus tachycardia, and myocardial ischemia. Data is reported as the cumulative number of participants with abnormalities over the scheduled collection timepoints.
Measured: Pre-dose, Day 1, Day 92, and Day 169
Number of Participants With Hypertension or Increased Blood Pressure
The number of participants who experienced hypertension or an increase in blood pressure from baseline up to Day 92. Abnormal blood pressure was defined as:
- Systolic blood pressure ≤ 90 or ≥ 180 mmHg
- Systolic blood pressure change (increase or decrease) ≥ 20 mmHg
- Diastolic blood pressure ≤ 60 or ≥ 100 mmHg
- Diastolic blood pressure change (increase or decrease) ≥ 15 mmHg
Measured: From baseline up to Day 92

Secondary outcomes (2)

Number of Participants With Skeletal-related Events (SRE)
Skeletal-related events are defined as pathologic fracture, radiation therapy to bone, surgery to bone, or spinal cord compression, within 2 weeks of study enrollment. They are determined by skeletal surveys, including x-rays of the skull, entire spine, pelvis, ribs, humeri, and femora.
Measured: From first dose up to 2 weeks post first dose
Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS)
The visual analog scale (VAS) is a pain rating scale. Scores are based on the percent change from baseline (Day 1) in self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain. The values can be used to track pain progression for a patient or to compare pain between patients with similar conditions. In addition to pain, the scale has also been used to evaluate mood, appetite, asthma, dyspepsia, and ambulation.
Measured: From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20081 Aug 2009

First posted4 Sep 2008 (estimated)
Study start1 Sep 2008
Primary completion1 Aug 2009
Study completion1 Aug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by CelgeneThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00747123
Sponsor's protocol ID: A011-04
Status last verified: Jun 2024
First submitted: 3 Sep 2008
Last updated: 3 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Abdulkadyrov KM, Salogub GN, Khuazheva NK, Sherman ML, Laadem A, Barger R, Knight R, Srinivasan S, Terpos E. Sotatercept in patients with osteolytic lesions of multiple myeloma. Br J Haematol. 2014 Jun;165(6):814-23. doi: 10.1111/bjh.12835. Epub 2014 Mar 21.
PubMed 24650009

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 3
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A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Multi-Center, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ACE-011 (hActRIIA-IgG1) in Patients With Osteolytic Lesions of Multiple Myeloma
ClinicalTrials.gov ID: NCT00747123
Acronym / sponsor ID: A011-04
Conditions: Multiple Myeloma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: CelgeneIndustry (pharma, biotech, devices)
Study start: 1 Sep 2008 (actual)
Primary completion: 1 Aug 2009 (actual)
Study completion: 1 Aug 2009 (actual)
First posted: 4 Sep 2008 (estimated)
Results: Posted 3 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Biological: PlaceboSubcutaneous injection on days 1, 29, 57 and 85.
ACE-011 0.1 mg/kg	Experimental	Biological: ACE-011Subcutaneous injection of ACE-011 0.1 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85).
ACE-011 0.3 mg/kg	Experimental	Biological: ACE-011Subcutaneous injection of ACE-011 0.3 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85).
ACE-011 0.5 mg/kg	Experimental	Biological: ACE-011Subcutaneous injection of ACE-011 0.5 mg/kg every 28 days totaling four doses (days 1, 29, 57 and 85).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patient at least 18 years of age with stage II or III multiple myeloma
One or more lytic bone lesions
If currently receiving bisphosphonate therapy, have been on a stable dose for ≥ 2 months before dosing day 1 or must not have received bisphosphonates within 2 months of dosing day 1
If patient has undergone previous autologous or allogenic hematopoietic stem cell transplantation (HSCT), they must be stable (in the opinion of the investigator) and be a minimum of 6 months since HSCT
Has planned HSCT for the duration of the study

Key exclusion criteria (10 listed)

Known underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions
History of polyneuropathy ≥ grade 3
Patients with plasma cell leukemia
Planned stem cell transplant (HSCT) or radiation for the duration of the study
Skeletal related event within 2 weeks of study enrollment

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
ACE-011Also: hActRIIA-IgG1ACE-011 given by the subcutaneous route of administration monthly for 4 doses.	Biological	ACE-011 0.1 mg/kg, ACE-011 0.3 mg/kg, ACE-011 0.5 mg/kg
PlaceboPlacebo given by the subcutaneous route of administration monthly for 4 doses.	Biological	Placebo

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose to termination visit on Day 169
A treatment emergent adverse event (TEAE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causality assessment. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug
Time frame: From first dose to termination visit on Day 169
A treatment emergent adverse event (TEAE) related to study drug was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, that was determined to be related to the study drug. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. Treatment emergent adverse events were assessed by the investigator as possibly, probably, or definitely related to the study drug.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From first dose up to termination visit on Day 169
A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that at any dose (including overdose) that was fatal, was life threatening, required or prolonged inpatient hospitalization, resulted in permanent or significant disability/incapacity, or was a congenital anomaly/birth defect. The number of participants with at least one serious adverse event are reported.
Change From Baseline in Hemoglobin
Time frame: Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169
Summary of the change from baseline in hemoglobin (g/dL) by the pre-specified timepoints. Baseline was defined as the last measurement prior to dosing. Data were summarized for all treated participants who had at least 1 postdosing measurement.
Number of Participants With Electrocardiogram Abnormalities
Time frame: Pre-dose, Day 1, Day 92, and Day 169
The number of participants with at least one clinically significant postbaseline electrocardiogram abnormality. The abnormalities included left ventricular hypertrophy, atrial fibrillation, sinus bradycardia, sinus tachycardia, and myocardial ischemia. Data is reported as the cumulative number of participants with abnormalities over the scheduled collection timepoints.
Number of Participants With Hypertension or Increased Blood Pressure
Time frame: From baseline up to Day 92
The number of participants who experienced hypertension or an increase in blood pressure from baseline up to Day 92. Abnormal blood pressure was defined as: * Systolic blood pressure ≤ 90 or ≥ 180 mmHg * Systolic blood pressure change (increase or decrease) ≥ 20 mmHg * Diastolic blood pressure ≤ 60 or ≥ 100 mmHg * Diastolic blood pressure change (increase or decrease) ≥ 15 mmHg

2 secondary outcomes

Number of Participants With Skeletal-related Events (SRE)
Time frame: From first dose up to 2 weeks post first dose
Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS)
Time frame: From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Results and safety

Results posted to the registry on 3 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	6	6
0.1 mg/kg ACE 011	8	6
0.3 mg/kg ACE 011	8	7
0.5 mg/kg ACE 011	8	7

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: From first dose to termination visit on Day 169. Count of participants. Unit: Participants

Measure	Placebo n = 6	0.1 mg/kg ACE 011 n = 8	0.3 mg/kg ACE 011 n = 8	0.5 mg/kg ACE 011 n = 8
Value	4	7	7	8

Population analysed: All randomized participants

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug

Time frame: From first dose to termination visit on Day 169. Count of participants. Unit: Participants

Measure	Placebo n = 6	0.1 mg/kg ACE 011 n = 8	0.3 mg/kg ACE 011 n = 8	0.5 mg/kg ACE 011 n = 8
Value	0	1	0	1

Population analysed: All randomized participants

Primary outcome: Number of Participants With Serious Adverse Events (SAEs)

Time frame: From first dose up to termination visit on Day 169. Count of participants. Unit: Participants

Measure	Placebo n = 6	0.1 mg/kg ACE 011 n = 8	0.3 mg/kg ACE 011 n = 8	0.5 mg/kg ACE 011 n = 8
Value	0	1	0	3

Population analysed: All randomized participants

Primary outcome: Change From Baseline in Hemoglobin

Time frame: Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169. Mean (Standard Deviation). Unit: g/dL

Measure	Placebo n = 6	0.1 mg/kg ACE 011 n = 8	0.3 mg/kg ACE 011 n = 8	0.5 mg/kg ACE 011 n = 8
Day 8	0.47 (0.288)	0.89 (1.254)	0.83 (0.599)	0.80 (0.844)
Day 29	0.50 (0.607)	-0.91 (1.844)	0.66 (0.457)	0.96 (1.648)
Day 36	1.02 (0.643)	0.73 (1.873)	1.00 (0.787)	1.48 (1.167)
Day 57	0.53 (0.602)	0.47 (1.682)	1.09 (1.022)	1.00 (1.22)
Day 85	0.78 (0.958)	0.57 (0.907)	0.86 (1.323)	1.56 (0.704)
Day 113	0.33 (0.789)	0.53 (1.141)	0.96 (1.620)	0.97 (1.024)
Day 169/Early Termination	0.13 (1.140)	0.57 (1.500)	0.33 (1.763)	0.03 (2.392)

Population analysed: All randomized participants

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 10 months). SAEs and Other AEs were assessed from first dose to Day 169.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACE 011 0.1 mg/kg	1 of 8 (12.5%)	7 of 8 (87.5%)	1 of 8
ACE 011 0.3 mg/kg	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
ACE 011 0.5 mg/kg	3 of 8 (37.5%)	8 of 8 (100%)	0 of 8
Placebo	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24650009Abdulkadyrov KM, Salogub GN, Khuazheva NK, Sherman ML, Laadem A, Barger R, Knight R, Srinivasan S, Terpos E. Sotatercept in patients with osteolytic lesions of multiple myeloma. Br J Haematol. 2014 Jun;165(6):814-23. doi: 10.1111/bjh.12835. Epub 2014 Mar 21.

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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.

Abderrahmane Laadem, MD study director

Celgene Corporation

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACE-011 in people with Multiple Myeloma, run by Celgene at 2 sites in Russia.

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 7 inclusion and 10 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: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From first dose to termination visit on Day 169). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00747123, which also lists 1 linked publication.

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 3 Oct 2024.