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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-25

Study Completion Date

2019-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma

NCT02144038

Relapsed and Refractory Multiple Myeloma

COMPLETED PHASE1

CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma

NCT04870944

Diffuse Midline Glioma, H3 K27-Altered Metastatic Malignant Neoplasm in the Central Nervous System Recurrent Diffuse Intrinsic Pontine Glioma +7 more

RECRUITING PHASE1/PHASE2

GVM±R in Patients With Relapsed or Refractory Aggressive NHL

NCT05299164

Non Hodgkin Lymphoma

ACTIVE_NOT_RECRUITING PHASE1

A Dose-escalation Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma

NCT04171843

Relapsed/Refractory Multiple Myeloma

TERMINATED PHASE1

A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma

NCT01432353

Multiple Myeloma

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LGH447

Eligible patients will be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity.

Group Type EXPERIMENTAL

LGH447

Intervention Type DRUG

LGH447 and midazolam

Eligible patients will receive midazolam on two separate days, the first dose will be administered prior to the start of LGH447 and the second will be co-administered with LGH447. After that, the patients will continue to be treated with oral LGH447 until disease progression or occurrence of unacceptable toxicity.

Group Type EXPERIMENTAL

LGH447

Intervention Type DRUG

midazolam

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LGH447

Intervention Type DRUG

midazolam

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No