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Completed

NCT Number: NCT01456689

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

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).

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Heidelberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LGH447

Drug

midazolam

Drug

Primary outcomes

  1. Estimate the MTD and/or RDE

    Time frame: 12 months

    Incidence rate of dose limiting toxicity

Secondary outcomes

  1. Number of participants with adverse events and serious adverse events.

    Time frame: 18 months

    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.

  2. Pharmacokinetic (PK) effects of LGH447

    Time frame: 18 months

    Summary of PK parameters such as AUC, Cmax,

  3. Pharmacodynamic (PD) effects of LGH447

    Time frame: 18 months

    Changes between pre and post treatment levels in bone marrow aspirates and whole blood.

  4. Anti-Myeloma activity associated with LGH447

    Time frame: 18 months

    Overall Response Rate (ORR), Duration of Response (DOR), and Progression Free Survival (PFS) based on International Myeloma Working Group Response Criteria.

  5. Effect of multiple-doses of LGH447 on the PK of midazolam

    Time frame: 6 months

    PK parameters of midazolam and 1-hydroxymidazolam, such as AUC and Cmax, as well as metabolic ratio of midazolam.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2011
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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