Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay

Micromedic Technologies

Status: Unknown

Conditions: Bisphosphonate-related Osteonecrosis of the Jaw

Treatments: Genetic: BRONJ

Study type: Interventional

Funder types: Industry

Identifiers

NCT02218554

CL-BNJ-001-PR

Details and patient eligibility

About

To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the "BRONJ Assay") in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous (IV) administration of Bisphosphonates (BP).

Full description

The Micromedic BRONJ Assay is intended for the qualitative analysis of genetic changes which may be indicative of increased risk to develop BRONJ osteonecrosis of the jaw (ONJ) following IV administration of drugs of the Bisphosphonate family.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion Criteria Study Group (all of the following):

1. Subject is ≥18 years old
2. Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the BP zoledronic acid and/or pamidronate disodium; Or; Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the BP zoledronic acid and/or pamidronate disodium and was also treated by oral BP such as sodium alendronate, and in the opinion of the PI, IV treatment was significant enough to be considered as the cause for BRONJ
3. Subject has been diagnosed with BRONJ at stages 1 or 2 or 3 according to AAOMS (American Association of Oral and Maxillofacial Surgeons)
4. Subject has signed the informed consent or consent can be waived

Inclusion Criteria Control Group (all of the following):

1. Subject is ≥18 years old
2. Subject is or was a Multiple Myeloma and/or other cancer patient who is, or has been IV treated with the BP zoledronic acid and/or pamidronate disodium for at least two (2) years (continuously or cumulatively)
3. Subject has not developed any signs or symptoms of BRONJ
4. Subject has signed the informed consent or consent can be waived

Exclusion criteria

1. Subject has been treated with irradiation to the jaws or head and neck at levels exceeding 35 Gy
2. Pregnant or lactating women
3. Subject has been treated with either bevacizumab or sunitimib
4. Subject has been treated with Allogeneic hematopoietic stem cell transplantation (HSCT)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Study Group

Experimental group

Description:

Subject has been diagnosed with BRONJ

Treatment:

Genetic: BRONJ

Control Group

No Intervention group

Description:

Subject has not developed any signs or symptoms of BRONJ