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Multiple Myeloma

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Bone Density Conservation Agents

All Drugs and Chemicals

Zoledronic Acid

Single arm biomarker study after a single dose of zoledronic acid

4mg IV over at least 15 minutes or corrected for creatinine clearance x 1

Zoledronic acid

Noopur Raje, MD

The purpose of this research study is to define the time a molecule in the participants bones called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in the urine to determine the rate of bone breakdown. Tracking this marker may help identify a more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic acid, which will be used in this study, are used to reduce pain and bone fractures in people with multiple myeloma. There is some laboratory data to suggest that they may work against myeloma. Participants will have already undergone bisphosphonate therapy and may have received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due to concerns of their long-term side effects we are looking at alternate strategies for reducing the frequency of these agents.

* Each participant will receive a single dose of zoledronic acid intravenously after the screening procedures.
* Participants will then return to the clinic once every month for 6 months and have the following tests and procedures performed: Medical history update; physical exam; ECOG (Eastern Cooperative Oncology Group) Performance Status; blood tests; and urine tests.
* After 6 months there will be an end of study visit, where the following procedures will take place: medical history update; bone marrow aspirate and biopsy; skeletal survey.

Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

A Phase II Study of Bone Marker Assessment of Multiple Myeloma Patients Treated With AminoBisphosphonates

Number of participants with urinary NTX levels less than or equal to 50 nmol/mmol creatinine (Cr) for the duration of study followup, following a single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1). Dose administration was followed by Aminobisphosphonates (aBP) treatment cessation during study period.

Brigham and Women's Hospital

Dana-Farber Cancer Institute

American Society of Clinical Oncology

Massachusetts General Hospital

Director Center for Multiple Myeloma

This was a nonintervention biomarker study after a single dose of Zoledronic acid.

Single Arm Study

Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Stage I

Stage II

Stage III

ISS Stage

Bortezomib + lenalidomide

Bortezomib + Other

Other

Therapy

Autologous Transplant

> 3 bone lesions

≤ 3 bone lesions

Bone Lesions

Only 6 month biomarker data--but sufficient to change dosing regimen

Dr Noopur Raje

Paired t-tests were used to compare differences of NTX cytokine levels at study entry versus end-of-study.

Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) treatment cessation during study period.

Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr

Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period.

Overall Study

Spots Global Cancer Trial Database for aminobisphosphonates