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 with relapsed or refractory multiple myeloma

• Conditions: adult patients with relapsed or refractory multiple myeloma; MedDRA version: 12.0Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2007-006279-35-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-27
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Inclusion criteria
1.Patients must have a diagnosis of active MM according to the International Myeloma Working Group criteria (Durie et al. 2006):
••Presence of an M-component in serum or urine (in patients with no detectable M-component, an abnormal FLC ratio on the serum FLC assay can substitute this criteria),
•Clonal Plasma cells in the bone marrow (= 10% of clonal plasma cells) and/or documented clonal plasmacytoma,
PLUS one or more of the following attributable to plasma cell disorder at the time of diagnosis:
•Calcium elevation (?11.5 mg/dl),
•Renal insufficiency (Creatinine ? 2 mg/dl),
•Anemia (Hemoglobin ? 10g/dl or 2g/dl ? normal),
•Bone disease (lytic lesions or osteopenia).
2.AUY922 single agent (Phase I dose escalation & Phase II dose expansion parts)
•Patients with relapsed-refractory MM (please refer to Post-text supplement 2) who received at least two but no more than three prior anti-myeloma regimens had progressed during or after the last therapy.
•Prior therapy must include at least one of the following: bortezomib or lenalidomide or thalidomide.
•Induction therapy followed by any kind of stem cell transplantation and/or maintenance therapy is considered as 1 regimen.
•AUY922 in combination (Phase Ib dose escalation part)
•Patients with relapsed-refractory MM (please refer to Post-text supplement 2) who received no more than two prior anti-myeloma regimens (excluding dexamethasone as single agent).
•Patients must be suitable (according to their local product information) for treatment with bortezomib. Note: patients previously treated with lenalidomide or thalidomide are eligible to participate in the trial.
•Induction therapy followed by any kind of stem cell transplantation and/or maintenance therapy is considered as 1 regimen.
5.Age = 18 years.
6.ECOG Performance Status of = 2.
7.Life expectancy of = 12 weeks.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with non-secretory MM.
2.Patients who have received allogenic stem cell transplantation ? 12 months prior to enter in the study.
3.Patients who have received allogenic stem cell transplantation and show evidence of active graft-versus-host disease that requires immunosuppressive therapy.
4.Patients with unresolved diarrhea = CTCAE grade 2.
5.Patients with acute or chronic liver disease.
6.Peripheral neuropathy = CTCAE grade 1 (only for patients in the combination part of the study).
7.Other concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
8.Pregnant or lactating women.
9.Fertile women of childbearing potential (WCBP) not using adequate contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile). Male patients whose partners are WCBP, not using adequate contraception.
10.Impaired cardiac function or clinically significant cardiac diseases, including any of the following:

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified