NCT00431990

Brief Summary

The purpose of the first phase of the study is to determine whether, and at what dose, depsipeptide, bortezomib and dexamethasone can be safely administered to patients with Multiple Myeloma. The second phase of the study will establish whether depsipeptide, bortezomib and dexamethasone is effective in the treatment of patients with multiple myeloma. The study will also examine the role of maintenance therapy with depsipeptide.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Nov 2006

Typical duration for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 12, 2011

Status Verified

August 1, 2011

Enrollment Period

5.1 years

First QC Date

February 4, 2007

Last Update Submit

August 11, 2011

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Toxicity

    Until progression

Secondary Outcomes (3)

  • Overall response

    Until progression

  • Time to progression

    Until progression

  • Overall survival

    Until progression

Interventions

depsipeptideDRUG

Cohort 1. Dose escalation, IV, Weeklyx3 in a 4week cycle. Cohort 2A. 12mg/m2, IV, Weeklyx3 in a 4week cycle. Cohort 2B. 12mg/m2, IV, Weeklyx2 in a 3week cycle.

Also known as: Romidepsin
bortezomibDRUG

Cohort 1 and 2A. 3.5mg/m2, IV, day 1, 4, 8, 11 in 28 day cycle. Cohort 2B. 3.5mg/m2, IV, day 1, 4, 8, 11 in 21 day cycle

Also known as: Velcade
dexamethasoneDRUG

20mg for 2 days with each dose of bortezomib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient was previously diagnosed with multiple myeloma based on standard criteria treated with at least one, but less than 4 lines of therapy, and currently requires further treatment because of relapse from CR or PD.
  • Patient previously treated with bortezomib will be included in the study, if the duration of response was \>6mths from the completion of therapy.
  • Patient's age is \> 18 yrs
  • Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
  • Patient has given voluntary written informed consent.
  • Female patients of child-bearing potential and male patients with female partners of child-bearing potential, one of whom has not undergone surgical sterilisation must agree to use 2 simultaneous methods of contraception. For female patients, a negative pregnancy test is to be performed within 7 days prior to administration of study drugs.
  • Patient has measurable disease.
  • serum monoclonal protein (SEP) \> 5 g/L
  • serum-free light chains (SFLC) \> 100 mg/L
  • urine-free light chains (UFLC) \> 200 mg/24hr
  • measurable soft tissue (not bone) plasmacytoma (STPC)
  • Patient has a Karnofsky performance status ≥80%.
  • Patient has a life-expectancy \>3 months.
  • Patient has the following laboratory values within 14 days before study drug administration:
  • Platelet count ≥50 × 109/L without transfusion support within 7 days
  • +8 more criteria

You may not qualify if:

  • Prior severe allergic reactions to bortezomib (Velcade), romidepsin, boron or mannitol
  • Neuropathy \> Grade 3 or Neuropathy of Grade 2 with pain \> Grade 1 by NCI-CTCAE criteria (v3.0).
  • Patients with the following cardiac risk factors will be excluded from the study (as per the previous NCI trials):
  • Congenital long QT syndrome
  • QTc interval \> 480 milliseconds
  • Patients who have had a myocardial infarction within 12 months of study entry.
  • Patients who have active coronary artery disease, e.g. angina as defined by Canadian Class II-IV (Appendix 3).
  • Patients with an ECG showing evidence of cardiac ischemia (ST depression of ≥ 2 mm).
  • Patients with congestive heart failure that meets NYHA Class II to IV definitions (Appendix 4) and/or ejection fraction \< 45% by MUGA scan or \< 50% by echocardiogram and/or MRI.
  • Patients with a history of sustained VT, VF, Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD).
  • Patients with dilated, hypertrophic, or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above).
  • Patients with uncontrolled hypertension, i.e. SBP ≥ 160 mm Hg or DBP ≥ 95 mm Hg.
  • Patients with cardiac arrhythmia requiring anti-arrhythmic medication other than beta blocker or calcium channel blocker. Patients in whom digitalis cannot be discontinued are excluded from study.
  • Patients with Mobitz II second degree heart block, that do not have a pacemaker.
  • Note: Patients with other cardiac disease may be excluded at the discretion of the principal investigator following consultation with cardiologist.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

RECRUITING

Related Publications (1)

  • Harrison SJ, Quach H, Link E, Seymour JF, Ritchie DS, Ruell S, Dean J, Januszewicz H, Johnstone R, Neeson P, Dickinson M, Nichols J, Prince HM. A high rate of durable responses with romidepsin, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma. Blood. 2011 Dec 8;118(24):6274-83. doi: 10.1182/blood-2011-03-339879. Epub 2011 Sep 12.

    PMID: 21911830DERIVED

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

DepsipeptidesromidepsinBortezomibDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, Fluorinated

Study Officials

  • Simon J Harrison, MBBS, PhD.

    Peter MacCallum Cancer Centre, Australia

    PRINCIPAL INVESTIGATOR

  • Miles Prince, MD

    Peter MacCallum Cancer Centre, Australia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne Dean

CONTACT

613 9656 1111Joanne.Dean@petermac.org

Sam Ruell

CONTACT

613 9656 1111Sam.Ruell@petermac.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2007

First Posted

February 6, 2007

Study Start

November 1, 2006

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

August 12, 2011

Record last verified: 2011-08

Locations

AU(1)