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Completed

NCT Number: NCT00111813

Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

The purposes of this study are:

* To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma * To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

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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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults with refractory or relapsed multiple myeloma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities)
  • Adequate bone marrow reserve
  • Adequate hepatic and renal function
  • Ability to swallow capsules
  • 3 weeks or more since prior chemotherapy and have recovered from prior toxicities

Exclusion criteria

  • Participants who plan to have a bone marrow transplant within 4 weeks of start of treatment
  • Participants with prior treatment with other investigational agents with a similar anti-tumor mechanism
  • Participants with other active/uncontrolled clinically significant illness
  • Pregnant or nursing female participants
  • Participants who received bortezomib within 3 months of start of this trial

Treatment and study plan

Vorinostat

Drug

Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).

Other names: MK0683, Zolinza®, Suberoylanilide Hydroxamic Acid (SAHA)

bortezomib

Drug

Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.

Other names: Velcade

Primary outcomes

  1. Mean Duration of Treatment With Vorinostat

    Time frame: Day 1 to an event causing discontinuation from the study, assessed up to 29 months

    Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity.

    Progressive disease was defined as:

    • >25% increase in the level of serum monoclonal paraprotein.
    • 25% increase in 24-hour urinary light chain excretion.
    • >25% increase in plasma cells in a bone marrow aspirate or on trephine

    biopsy.

    • Development of new bone lesions or soft tissue plasmacytomas.
    • Development of hypercalcemia.

    Intolerable toxicity was based on the clinical judgment of the investigator.

Secondary outcomes

  1. Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug

    Time frame: Day 1 to disease progression, toxicity, or death, assessed up to 29 months

    An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.

  2. Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib

    Time frame: Day 1 to disease progression, toxicity, or death, assessed up to 29 months

    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.

  3. Clinical AE Summary

    Time frame: Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)

    An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.

    A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.

  4. Laboratory AE Summary

    Time frame: Day 1 up to disease progression, toxicity, or death, assessed up to 29 months

    An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.

    A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.

    A lab (S)AE was any lab value considered clinically significant in the investigator's judgment.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma

Important dates

Study start
2005
Primary completion
2009
Study completion
2011
First posted
May 26, 2005
Registry last updated
May 21, 2015

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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