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NCT01456689 Clinical Trial

A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01456689
Other study ID # CLGH447X2101
Secondary ID 2011-003820-10
Status Completed
Phase Phase 1
First received
Last updated
Start date April 25, 2012
Est. completion date June 5, 2019

Study information
Verified date October 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this dose escalation study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of LGH447 as a single agent when administered orally once daily to adult patients with Multiple Myeloma (MM).

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date June 5, 2019
Est. primary completion date June 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmed diagnosis of multiple myeloma that is relapsed and/or refractory for which no curative option exists. - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. - During the dose expansion part of the study patients must have measurable disease defined by at least 1 of the following 2 measurements: - Serum M-protein = 0.5 g/dL - Urine M-protein = 200 mg/24 hours - Serum free light chain (FLC) > 100 mg/L of involved FLC Exclusion Criteria: - Patients who are currently receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with LGH447: - Strong inhibitors or inducers of CYP3A4 - CYP3A4 substrates with narrow therapeutic index Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LGH447

• midazolam

Locations
Country Name City State
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Kiel
Singapore Novartis Investigative Site Singapore
Spain Novartis Investigative Site Salamanca Castilla Y Leon
United States Novartis Investigative Site Ann Arbor Michigan
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Singapore,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Estimate the MTD and/or RDE Incidence rate of dose limiting toxicity 12 months
Secondary Number of participants with adverse events and serious adverse events. Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. 18 months
Secondary Pharmacokinetic (PK) effects of LGH447 Summary of PK parameters such as AUC, Cmax, 18 months
Secondary Pharmacodynamic (PD) effects of LGH447 Changes between pre and post treatment levels in bone marrow aspirates and whole blood. 18 months
Secondary Anti-Myeloma activity associated with LGH447 Overall Response Rate (ORR), Duration of Response (DOR), and Progression Free Survival (PFS) based on International Myeloma Working Group Response Criteria. 18 months
Secondary Effect of multiple-doses of LGH447 on the PK of midazolam PK parameters of midazolam and 1-hydroxymidazolam, such as AUC and Cmax, as well as metabolic ratio of midazolam. 6 months
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Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
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