Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577642
• Other study ID #: 07-144
• Secondary ID: ASCO CDA
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2007
• Last updated: May 7, 2013
• Start date: October 2007
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 or PR 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Zoledronic acid
4mg IV over at least 15 minutes or corrected for creatinine clearance x 1

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Society of Clinical Oncology, Brigham and Women's Hospital, Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the proportion of patients with urinary NTX levels less than or equal to 50nmol/mmol following a single dose of zoledronic acid.		6 months	Yes
Secondary	Gather baseline information on markers of disease activity, bone turnover, bone remodeling, and osteoclast activating factors in this patient population.		6 months	Yes