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

• Sponsor: Instituto Mexicano del Seguro Social (Other)
• Overall Status: Completed
• CT.gov ID: NCT01234129
• Collaborator: (none)
• Enrollment: 320
• Location: 1
• Duration (Months): 90
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: zoledronic acid

Detailed Description

Assess if the use of zoledronic acid can improve outcome in patients with multiple myeloma whose are treated with cytoreductive therapy and stem cell transplant.

Study Design

• Study Type: Observational
• Actual Enrollment: 320 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Results of Phase III Study to Assess if Zoledronic Acid Have Antumor Activity in Multiple Myeloma
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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, 4 mg,standard dose,at monthly interval, by 2 years
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, 4 mg,standard dose,at monthly interval, by 2 years
zoledronic acid Patients with multiple treated with cytoreductive therapy following by stem cell transplant will be planned to received zoledronic acid	Drug: zoledronic acid; zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years

Outcome Measures

Primary Outcome Measures

1. progression-free disease and overall toxicity in myeloma multiple [3 years]

   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

Secondary Outcome Measures

1. skeletal event [3 years]

   evaluate the number of skeletal events in patients with multiple myeloma that received zoledronic acid

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy HIV + Refuse treatment

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tertiary reference oncology center	Mexico	Distrito Federal	Mexico	06725

Sponsors and Collaborators

• Instituto Mexicano del Seguro Social

Investigators

• Principal Investigator: Agustin Aviles, MD, Instituto Mexicano del Seguro Social

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01234129
• Other Study ID Numbers: kitty1; kitty2
• First Posted: Nov 4, 2010
• Last Update Posted: Nov 4, 2010
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: multiple myeloma; stem cell transplant; zoledronic acid
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Zoledronic Acid

Study Results

No Results Posted as of Nov 4, 2010