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Technology Platform and System Construction of Clinical Evaluation Studies on New Drugs of Hematological Malignancy

NCT01250808 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2010-12-01

No results posted yet for this study

Summary

Multiple Myeloma (MM) is the second diagnosed malignancy of hematological malignancies. The previous study pointed out that the dosage and course of Bortezomib including the dose of concomitant drugs used to treatment MM patients did not get the preferred treatment program, so we are going to determine the optimal doses and course of Bortezomib through the prospective, multicenter clinical trial and evaluate the efficiency and safety of different program.

Conditions

Interventions

DRUG

Bortezomib/Dexamethasone/Melphalan

Induction therapy: The treatment will continue for 3-4 cycles and each cycle will be last 21 days. Bortezomib 1.3mg/m2, twice weekly for two weeks (days 1, 4, 8, and 11) of each cycle + Dexamethasone 20mg/m2, on days 1-4 of each cycle. Bortezomib 1.0mg/m2, twice weekly for two weeks (days 1, 4, 8, and 11) of each cycle + Dexamethasone 20mg/m2, on days 1-4 of each cycle. Bortezomib 1.6mg/m2, once weekly for two weeks (days 1, 8) of each cycle + Dexamethasone 20mg/m2, on days 1-4 of each cycle and on days 9-12 of the first and second cycles. ASCT therapy: Melphalan 200mg/m2 +Bortezomib 1.0mg/m2 for four times. Melphalan 200mg/m2 +Bortezomib 1.0mg/m2 for two times.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01250808 on ClinicalTrials.gov