| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Ixazomib | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Bone Healing During Ninlaro Exposure. An Open Label Phase 2 Single Centre Clinical Trial |
| Actual Study Start Date : | October 24, 2019 |
| Estimated Primary Completion Date : | July 8, 2022 |
| Estimated Study Completion Date : | January 8, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Interventional
Patients included in the trial will be treated with Ixazomib 4 mg on day 1, 8, and 15 in a 28-day cycle for up to 24 cycles. In this, study no randomisation will occur. All patients will receive the same treatment.
|
Drug: Ixazomib
Scheduled visits: Patients included in the trial will be treated with Ixazomib 4 mg on day 1, 8, and 15 in a 28-day cycle for up to 24 cycles. Patients will be evaluated every 4th week by a medical doctor, prior to initiation of a new cycle of Ixazomib.
Other Name: Ninlaro
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female patients who
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following
Exclusion Criteria:
| Contact: Thomas Lund, Ph.D., MD | 004521450256 | thomas.lund2@rsyd.dk |
| Denmark | |
| Odense University Hospital | Recruiting |
| Odense, Denmark, 5000 | |
| Contact: Thomas Lund, Ph.D. 21450256 ext +45 thomas.lund2@rsyd.dk | |
| Principal Investigator: | Thomas Lund, Ph.D., MD | Odense University Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 17, 2019 | ||||
| First Posted Date ICMJE | July 22, 2019 | ||||
| Last Update Posted Date | March 25, 2020 | ||||
| Actual Study Start Date ICMJE | October 24, 2019 | ||||
| Estimated Primary Completion Date | July 8, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Healing of osteolytic bone lesions on low dose CT. [ Time Frame: from the inclusion in the protocol until the patient has been in the protocol for 24 months or until the patient leaves the protocol if that happens before 24 months ] Healing of osteolytic bone lesions on low dose CT. Healing will be evaluated based on the preexisting lesion on low dose CT required upon inclusion. All lesions will be evaluated individually using the inclusion scanning as reference. Healing will be defined as ≥ 25% reduction in the size of osteolytic lesions (a reduction of at least 2 mm in the longest dimension is required), increased sclerosis in the edge of existing lesions, or healing of existing lesions.
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bone Healing During Ninlaro Exposure | ||||
| Official Title ICMJE | Bone Healing During Ninlaro Exposure. An Open Label Phase 2 Single Centre Clinical Trial | ||||
| Brief Summary | The primary purpose of this study is to investigate if treatment with Ixazomib in multiple myeloma (MM) can strengthen the bones, thus making it resilient to future fractures. Ixazomib will be given at a time point when the disease is in a stable phase, decreasing the likelihood that the potential bone anabolic effect will be abrogated by catabolic effect of active MM. In order to be included in the study, the patient must have treatment demanding MM, and the disease must have been brought into at least partial remission with chemotherapy before inclusion. Moreover, the patient must have pathological bone structure on low dose CT due to the pre-existing disease. | ||||
| Detailed Description | The primary purpose of this study is to investigate if treatment with Ixazomib in multiple myeloma (MM) can strengthen the bones, thus making it resilient to future fractures. Ixazomib will be given at a time point when the disease is in a stable phase, decreasing the likelihood that the potential bone anabolic effect will be abrogated by catabolic effect of active MM. In order to be included in the study, the patient must have treatment demanding MM, and the disease must have been brought into at least partial remission with chemotherapy before inclusion. Moreover, the patient must have pathological bone structure on low dose CT due to the pre-existing disease. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE | Multiple Myeloma | ||||
| Intervention ICMJE | Drug: Ixazomib
Scheduled visits: Patients included in the trial will be treated with Ixazomib 4 mg on day 1, 8, and 15 in a 28-day cycle for up to 24 cycles. Patients will be evaluated every 4th week by a medical doctor, prior to initiation of a new cycle of Ixazomib.
Other Name: Ninlaro
|
||||
| Study Arms ICMJE | Experimental: Interventional
Patients included in the trial will be treated with Ixazomib 4 mg on day 1, 8, and 15 in a 28-day cycle for up to 24 cycles. In this, study no randomisation will occur. All patients will receive the same treatment.
Intervention: Drug: Ixazomib
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
30 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | January 8, 2023 | ||||
| Estimated Primary Completion Date | July 8, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Female patients who
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | Denmark | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04028115 | ||||
| Other Study ID Numbers ICMJE | HFE-X 18.01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Thomas Lund, Odense University Hospital | ||||
| Study Sponsor ICMJE | Thomas Lund | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| PRS Account | Odense University Hospital | ||||
| Verification Date | March 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||