Trial · NCT04028115
Bone Healing During Ninlaro Exposure
NCT04028115, Phase 2, Completed, Thomas Lund
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bone Healing During Ninlaro Exposure. Trials, record NCT04028115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04028115
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bone Healing During Ninlaro Exposure
- NCT number
- NCT04028115
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Thomas Lund
- Conditions
- Multiple Myeloma
- Interventions
- Ixazomib
- First posted
- 2019-07-22
- Last updated
- 2024-04-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Healing of osteolytic bone lesions on low dose CT. | 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. |
| Secondary | Increased bone formation during Ixazomib treatment in NaF PET. | 3, 12 and 24 months | Increased bone formation during Ixazomib treatment in NaF PET. Increased bone formation will be evaluated in NaF PET by comparing delta values of SUVmax of the individual lesions. The inclusion scan will be used as reference. NaF PET scan will be conducted 45 (+/-5 minutes) minutes after infusion of the NaF tracer. |
| Secondary | Increased bone anabolism during Ixazomib treatment. | 3, 12 and 24 months | Increased bone anabolism during Ixazomib treatment. The bone anabolic markers bALP, PINP, and OC will be measured at screening and during treatment. The patient will function as his or her own control, using the bone marker levels at inclusion as reference. |
| Secondary | Increased bone formation to bone degradation ratio during Ixazomib treatment. | 3, 12 and 24 months | Increased bone formation to bone degradation ratio during Ixazomib treatment. In addition to the anabolic bone markers; the degradation markers CTX and TRAP5b will also be measured. Again using the levels at inclusion, a ratio of bone formation to bone degradation markers will be calculated. Delta values will be calculated during Ixazomib treatment to investigate if bone remodeling changes toward a more anabolic equilibrium. |
| Secondary | Increased bone formation using bone histomorphometric evaluation. | 3, 12 and 24 months | Increased bone formation using bone histomorphometric evaluation. At inclusion and at predefined selected time points, the patient will have a bone marrow biopsy performed. This biopsy will be stored for later evaluation. Evaluation will be conducted using a slightly modified Masson trichrome staining. |
| Secondary | Changes in the patients' mesenchymal stroma cells toward a more osteoblastic state. | 3, 12 and 24 months | Changes in the patients' mesenchymal stroma cells toward a more osteoblastic state. At inclusion and after three months, the patients will have a bone marrow biopsy performed. Stromal cells will be harvested, characterized by Cluster of Differentiation markers, methylation changes, global mRNA expression, and grown in culture assays to investigate their osteoblastic potential. |
| Secondary | Investigate safety and toxicities during Ixazomib treatment. | 2 years | Investigate safety and toxicities during Ixazomib treatment. Ixazomib has been approved by EMEA in combination with Lenalidomide and Dexamethasone in patients who has relapse of MM after initial therapy. Here, we also wish to give Ixazomib after initial therapy has been completed. However, we wish to give it as monotherapy to patients who do not have active disease. Any toxicity during the study will be registered and graded according to NCI CTCAE version 4 National Cancer Institute Common Terminology Criteria for Adverse Events. (Most recent version can be found at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm). |
| Secondary | Depth of cancer response to Ixazomib treatment. | 2 years | Depth of cancer response to Ixazomib treatment. Ixazomib has an anti-myeloma effect. During the trial, serum and urine M-component as well as serum free light kappa and lambda chains will be measured. Any upgrading of depth of response will be measured in relation to the status prior to the preexisting disease levels before the last treatment was initiated. In addition, changes in disease status during treatment compared to disease burden at inclusion will also be investigated. Bone marrow examination will be done to verify CR. Response is measured according to the International Myeloma Working Group Uniform Response Criteria (2016) appendix 1. |
| Secondary | Adherence to therapy. | 2 years | Adherence to therapy. Ixazomib will be given for up to 24 cycles or until disease progression (biochemical or symptomatic), see appendix 1 for details, unacceptable toxicities, or withdrawal of consent. In the study we will register time on treatment and reason for discontinuation. As a subpart of this, we will also register time to disease progression during Ixazomib treatment, by calculating from the time when the last treatment was initiated and stopped. |
| Secondary | Healing of osteolytic bone lesions on low dose CT. | 3, 12, and 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40998041 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04028115
GET https://conductscience.org/api/trials/v1/NCT04028115/registered