Multiple MyelomaAMBROBiMMNCT04111809
Study of 4 Bone Turnover Markers in Patients With Multiple Myeloma Treated With Intravenous Bisphosphonate in Routine Care
An observational study of Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is looking at the Kinetics of bone turnover markers (C-terminal telopeptides of type I collagene (CTX), amino-terminal telopeptide of type 1 collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in serum and urine until 12 months in Patients with Multiple Myeloma Treated With intravenous… Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Blood and urine collection
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2020to 20 Oct 2020
- Phase
- Observational
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Study population: no description
Who may be able to join
- Patient aged 65 to 75 years of age
- Patient with symptomatic multiple myeloma as defined by the criteria of the IMWG
- Need to introduced an antiresorptive bone treatment by intravenous bisphosphonate with bone imaging mapping (PET-scanner preferentially) in routine care
- Ability and willingness to follow scheduled visits with requested biological samples
Who cannot join
- Patients previously treated with intravenous biphosphonate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of 4 Bone Turnover Markers (C-terminal Telopeptides of Type I Collagene (CTX), Amino-terminal Telopeptide of Type 1 Collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in Multiple Myeloma Patients Treated With Intravenous Bisphosphonate
The aim of this study is looking at the Kinetics of bone turnover markers (C-terminal telopeptides of type I collagene (CTX), amino-terminal telopeptide of type 1 collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in serum and urine until 12 months in Patients with Multiple Myeloma Treated With intravenous bisphosphonates in routine care.
- Conditions
- Multiple Myeloma
- Being tested
- Blood and urine collection
- Keywords
- Multiple Myeloma, intravenous bisphosphonate, bone markers
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine collectionBiological
collected 10 mL of blood and 15 mL of urine every 2 months until 12 months
| Study group | Role | What they receive |
|---|---|---|
| intravenous biphosphonate | Patients treated with intravenous bisphosphonate until 12 months in routine care Receives: Biological: Blood and urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone turnover markers
bone turnover markers include: C-terminal telopeptides of type I collagene (CTX) in serum, amino-terminal telopeptide of type 1 collagen (NTX) in urine, Dickkopf-1 (DKK-1) and Sclerostin (SOST) in plasma
Measured: Baseline, then every 2 months in 12 months
Secondary outcomes (7)
time to maximum variation of bone turnover markers
CTX, NTX, DKK-1 and SOST
Measured: Baseline, then every 2 months in 12 months
Doses of intravenous bisphosphonate
To study the relationship between doses and bone turnover markers
Measured: Up to 12 months
Rate of intravenous bisphosphonate
To study the relationship between doses and bone turnover markers
Measured: Up to 12 months
evolution of bone lesions by imaging
evolution of bone lesions by imaging
Measured: Up to 12 months
Number of new bone events
Measured: Up to 12 months
Number of adverse events likely to be related to bisphosphonate
Measured: Up to 12 months
Changes in Monoclonal protein
To evaluated response to treatment
Measured: Baseline, then every 2 months in 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start29 Sep 2020
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Why it stopped: Inability to conduct the study
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 Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Intergroupe Francophone du Myelome, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111809
- Sponsor's protocol ID
- APH190198
- Acronym
- AMBROBiMM
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2019
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of 4 Bone Turnover Markers (C-terminal Telopeptides of Type I Collagene (CTX), Amino-terminal Telopeptide of Type 1 Collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in Multiple Myeloma Patients Treated With Intravenous Bisphosphonate
- ClinicalTrials.gov ID
- NCT04111809
- Acronym / sponsor ID
- AMBROBiMM / APH190198
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, intravenous bisphosphonate, bone markers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inability to conduct the study
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Intergroupe Francophone du Myelome, URC-CIC Paris Descartes Necker Cochin
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 1 Oct 2019 (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.
The aim of this study is looking at the Kinetics of bone turnover markers (C-terminal telopeptides of type I collagene (CTX), amino-terminal telopeptide of type 1 collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in serum and urine until 12 months in Patients with Multiple Myeloma Treated With intravenous bisphosphonates in routine care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravenous biphosphonate | – | Biological: Blood and urine collectionPatients treated with intravenous bisphosphonate until 12 months in routine care |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- no description
Key inclusion criteria (4 listed)
- Patient aged 65 to 75 years of age
- Patient with symptomatic multiple myeloma as defined by the criteria of the IMWG
- Need to introduced an antiresorptive bone treatment by intravenous bisphosphonate with bone imaging mapping (PET-scanner preferentially) in routine care
- Ability and willingness to follow scheduled visits with requested biological samples
Key exclusion criteria (1 listed)
- Patients previously treated with intravenous biphosphonate
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 |
|---|---|---|
| Blood and urine collectioncollected 10 mL of blood and 15 mL of urine every 2 months until 12 months | Biological | intravenous biphosphonate |
Primary outcome
Changes in bone turnover markers
Time frame: Baseline, then every 2 months in 12 months
bone turnover markers include: C-terminal telopeptides of type I collagene (CTX) in serum, amino-terminal telopeptide of type 1 collagen (NTX) in urine, Dickkopf-1 (DKK-1) and Sclerostin (SOST) in plasma
7 secondary outcomes
time to maximum variation of bone turnover markers
Time frame: Baseline, then every 2 months in 12 months
Doses of intravenous bisphosphonate
Time frame: Up to 12 months
Rate of intravenous bisphosphonate
Time frame: Up to 12 months
evolution of bone lesions by imaging
Time frame: Up to 12 months
Number of new bone events
Time frame: Up to 12 months
Number of adverse events likely to be related to bisphosphonate
Time frame: Up to 12 months
Changes in Monoclonal protein
Time frame: Baseline, then every 2 months in 12 months
Results and safety
The study was stopped early (reason given: Inability to conduct the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Sep 2025. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: Inability to conduct the study). Results are not available in the source record.
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?
Changes in bone turnover markers (time frame: Baseline, then every 2 months in 12 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 25 Sep 2025.