Neoplasms

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Multiple Myeloma

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Anti-Infective Agents

Ixazomib

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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.

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.

Thomas Lund, Ph.D., MD

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.

Bone Healing During Ninlaro Exposure

Bone Healing During Ninlaro Exposure. An Open Label Phase 2 Single Centre Clinical Trial

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.

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.

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.

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.

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.

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.

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).

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bone Healing During Ninlaro Exposure	NCT04028115	Multiple Myelom...	Ixazomib	18 Years -	Odense University Hospital
Bone Healing During Ninlaro Exposure	NCT04028115	Multiple Myelom...	Ixazomib	18 Years -	Odense University Hospital

Spots Global Cancer Trial Database for wh 540

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Spots Global Cancer Trial Database for wh 540

Every month we try and update this database with for wh 540 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for wh 540 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.