NCT00733538

Brief Summary

  • Assessment of survival without progression of stage I MM in two groups: arm A: simple survey and arm B: administration of Zoledronate.
  • Describe different progression's type noticed and define the prognosis factors of a fast evolution.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P25-P50 for phase_4 multiple-myeloma

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_4 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 12, 2024

Status Verified

February 1, 2009

Enrollment Period

4.9 years

First QC Date

August 12, 2008

Last Update Submit

April 11, 2024

Conditions

Multiple Myeloma

Keywords

stage I multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Survival without progress

    every month during 6 years

Secondary Outcomes (2)

  • predictive factors of a fast evolution of multiple myeloma

    every month during 6 years

  • Secondary effects of zolédronate

    every month during six years

Study Arms (2)

1

ACTIVE COMPARATOR

patients receiving zometa treatment

Drug: zometa

2

NO INTERVENTION

No treatment, just follow-up

Interventions

zometaDRUG

patients receiving treatment during their follow-up

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stage I multiple myeloma without bones injuries

You may not qualify if:

  • abnormal kidney function
  • VIH infection
  • Hepatic incapacity
  • pregnancy
  • Associate pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Medecine interne, Hôpital l'ARCHET, CHU de Nice

Nice, 06202, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jean-Gabriel FUZIBET, PU-PH

    service de médecine interne, CHU de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 13, 2008

Study Start

December 1, 2004

Primary Completion

November 1, 2009

Study Completion

November 1, 2012

Last Updated

April 12, 2024

Record last verified: 2009-02

Locations

FR(1)