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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the proportion of patients with urinary NTX levels less than or equal to 50nmol/mmol following a single dose of zoledronic acid.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Noopur Raje, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

07-144

NCT ID:

NCT00577642

Start Date:

October 2007

Completion Date:

December 2012

Related Keywords:

  • Multiple Myeloma
  • aminobisphosphonates
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617