Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

NCT00577642 | Completed Phase 2 Results

• 2 other identifiers: 07-144ASCO CDA
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

aminobisphosphonates

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 months

Study Arms (1)

Single arm

OTHER

Single arm biomarker study after a single dose of zoledronic acid

Drug: Zoledronic acid

Interventions

Zoledronic acid DRUG

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

Also known as: Zometa

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• Dana-Farber Cancer Institute: collaborator
• American Society of Clinical Oncology: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 24958808 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Dr Noopur Raje
• Organization: Massachusetts General Hospital

nraje@partners.org

6177260711

Study Officials

• Noopur Raje, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Center for Multiple Myeloma

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 10, 2017
• Results First Posted: March 10, 2017

Record last verified: 2017-01

Locations

US (1)