NCT Number: NCT00708292
A Phase I-Ib/II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 Alone and in Combination With Bortezomib, With or Without Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma.
This is a Phase I-Ib/II, open-label, multicenter study of AUY922 administered intravenously in patients with multiple myeloma to determine the maximum tolerated dose. The Phase II part will investigate the efficacy of AUY922 in patients with multiple myeloma. Additionally, the study includes a Phase Ib combination part of AUY922 administered in combination with bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with multiple myeloma.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Novartis Investigative Site, Melbourne, Australia
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients must have a diagnosis of active multiple myeloma.
- Phase I and Phase II part: Patients must have received at least 2 but not more than 4 prior line of therapy and their disease has progressed during or after last therapy.
- Phase Ib part: Patients must have received no more than 2 prior lines of therapy (excluding dexamethasone as single agent).
- ECOG Performance Status of ≤ 2.
- Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function.
- Patients must have magnesium levels above lower limit of normal or correctable with supplements.
- Patients must be willing and able to undergo bone marrow biopsy/aspirate.
- Able to sign informed consent.
Exclusion criteria
- Prior treatment with any HSP90 or HDAC inhibitor for the treatment of multiple myeloma.
- Patients with unresolved diarrhea ≥ CTCAE grade 2.
- Patients with acute or chronic liver disease.
- Patients using medications that have a relative risk of prolonging the QT interval.
- Clinically significant cardiac diseases.
- Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g. Gilbert's syndrome).
- Pregnant or lactating women.
- Fertile women of childbearing potential (WCBP) not using adequate contraception.
- Male patients whose partners are WCBP, not using adequate contraception.
- Patients who unwilling or unable to comply with the protocol.
- Phase Ib part: Peripheral neuropathy ≥ CTCAE grade 1.
- Phase Ib part: Prior treatment with bortezomib.
Other protocol-defined inclusion/exclusion criteria may apply
Treatment and study plan
bortezomib
DrugDexamethasone
DrugPrimary outcomes
-
The safe dose of AUY922 when administered once a week.
Time frame: 54 weeks (Maximum Tolerated Dose (MTD))
Secondary outcomes
-
The safe dose of AUY922 when administered once a week in combination with bortezomib and dexamethasone.
Time frame: 24 weeks (MTD determination of dual and triple combination)
-
Efficacy of AUY922 administered once a week alone and in combination
Time frame: at baseline and every 2 cycles (time to document tumor progression)
Sponsors and collaborators
Lead sponsor
Novartis Pharmaceuticals
Industry
Registry information
Official study title
An Open-label, Multi-center, Phase I-Ib/II Study of AUY922 Administered as Single Agent and in Combination With Bortezomib With or Without Dexamethasone in Adult Patients in Relapse or Refractory Multiple Myeloma.
Important dates
- Study start
- 2008
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Jul 2, 2008
- Registry last updated
- Dec 17, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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