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NCT00577642 · REGISTRY CONDITION SEARCH

Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-03-10

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Single arm biomarker study after a single dose of zoledronic acid
    intervention Names
    1. Drug: Zoledronic acid
    label
    Single arm
    type
    OTHER
interventions
  1. arm Group Labels
    1. Single arm
    description
    4mg IV over at least 15 minutes or corrected for creatinine clearance x 1
    name
    Zoledronic acid
    other Names
    1. Zometa
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
29
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr
    time Frame
    6 months
Full study description
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.
Source references
references
  1. citation
    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
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
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      edge id
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      payload
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      true
      id
      nct-edge-9d39a992b60ccef06906
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      nct id
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      occurrences
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        exact text
        NCT00577642
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
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      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice