Stem Cell Transplant and Zoledronic Acid Improve Outcome in Previously Untreated Patients With Multiple Myeloma

NCT01234129 | Completed

• 2 other identifiers: kitty1kitty2
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; stem cell transplant; zoledronic acid

Outcome Measures

Primary Outcomes (1)

• progression-free disease and overall toxicity in myeloma multiple

  In patients treated with cytoreductive therapy following by stem cell transplant and that received zoledronic acid by 2 years,they were evaluable for assess antitumor effect of zoledronic acid

  3 years

Secondary Outcomes (1)

• skeletal event

  3 years

Study Arms (3)

zoledronic acid or not zoledronic acid

patients with multiple myeloma will be treated with cytoreductive therapy following by zoledronic acid or not.

Drug: zoledronic acid

zoledronic acid or not zoledronic acid

patients with multiple myeloma will be treated with cytoreductive therapy following by stem cell transplant and did not received zoledronic acid

Drug: zoledronic acid

zoledronic acid

Patients with multiple treated with cytoreductive therapy following by stem cell transplant will be planned to received zoledronic acid

Drug: zoledronic acid

Interventions

zoledronic acid DRUG

zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years

zoledronic acid; zoledronic acid or not zoledronic acid

Eligibility Criteria

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

Study Population

Patients with multiple myeloma previously untreated

You may qualify if:

• Diagnosis of multiple myeloma No previous treatment Symptomatic High risk (ISS) or stage III ( Durie-Salmon) No severe comorbidities -

You may not qualify if:

• Pregnancy HIV + Refuse treatment

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Tertiary reference oncology center

Mexico City, Mexico City, 06725, Mexico

Location

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

Study Officials

• Agustin Aviles, MD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 4, 2010
• Study Start: June 1, 2002
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 4, 2010

Record last verified: 2009-12

Locations

ME (1)