Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

NCT ID: NCT00577642

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2012-12-31

Brief Summary

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.

Detailed Description

• 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Single arm biomarker study after a single dose of zoledronic acid

Group Type: OTHER

Zoledronic acid

Intervention Type: DRUG

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

Interventions

Zoledronic acid

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

Intervention Type: DRUG

Other Intervention Names

Zometa

Eligibility Criteria

Inclusion Criteria

• Men or women 18 years of age or older
• Confirmed diagnosis of multiple myeloma(MM) by Durie and Dalmon staging criteria on IV bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months
• MM patients in either CR (complete response) or PR (partial response) by EBMT criteria
• ECOG Performance Status of 0-2

Exclusion Criteria

• MM patients on active anti-MM therapy (maintenance regimens allowed)
• Renal failure with serum creatinine >2mg/dL and/or creatinine clearance of <30ml/min
• Relapsed, refractory or progressive disease
• Any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study
• Hypersensitivity or any contraindication to a single dose of zoledronic acid

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

American Society of Clinical Oncology

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Noopur Raje

Director Center for Multiple Myeloma

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noopur Raje, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Patel CG, Yee AJ, Scullen TA, Nemani N, Santo L, Richardson PG, Laubach JP, Ghobrial IM, Schlossman RL, Munshi NC, Anderson KC, Raje NS. Biomarkers of bone remodeling in multiple myeloma patients to tailor bisphosphonate therapy. Clin Cancer Res. 2014 Aug 1;20(15):3955-61. doi: 10.1158/1078-0432.CCR-14-0434. Epub 2014 Jun 23.

Reference Type: BACKGROUND

PMID: 24958808 (View on PubMed)

Other Identifiers

ASCO CDA

Identifier Type: -

Identifier Source: secondary_id

07-144

Identifier Type: -

Identifier Source: org_study_id