NCT00508209

Brief Summary

The prognosis after retreating with high-dose melphalan with stem cell support after first relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can increase chemosensitivity of e.g. melphalan. The trial aims at determining the toxicity of adding bortezomib to high-dose melphalan with stem cell support and evaluating whether the time to a second relapse can be prolonged.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Jul 2007

Geographic Reach
3 countries

9 active sites

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

July 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

1.9 years

First QC Date

July 26, 2007

Last Update Submit

June 17, 2010

Conditions

Multiple Myeloma

Keywords

high-dose melphalanbortezomibresponsetoxicityrelapse

Outcome Measures

Primary Outcomes (1)

  • Comparison of the event free survival after first high-dose melphalan with stem cell support (ASCT) and a second ASCT combined with bortezomib treatment of first relapse

    3 years

Secondary Outcomes (4)

  • Determining the toxicity of bortezomib as part of the high-dose melphalan conditioning

    3 years

  • Response rate of the second ASCT

    3 years

  • Marrow regeneration

    3 years

  • OS compared with the OS of matched controls from the former NMSG

    3 years

Interventions

bortezomibDRUG

1.3 mg/sqm days -5 and -2 in connection with high-dose melphalan (200mg/sqm day -2) and autologous stem cell support

Also known as: Velcade

Eligibility Criteria

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

You may qualify if:

  • First relapse after ASCT
  • Symptomatic myeloma
  • More than 2,0 x 10\^6 CD34+ stem cells / kg bodyweight in the freezer for stem cell support
  • Signed informed consent given prior to any study related activities have been performed
  • Age \> 18 years

You may not qualify if:

  • Allogeneic transplantation scheduled as a part of the treatment
  • Expected survival of less than one month.
  • Performance status (WHO) \> 3
  • Neuropathy \> Grade 3 (neurological symptoms interfering with ADL)
  • Non-secreting myeloma
  • Other concurrent disease making bortezomib treatment unsuitable
  • Positive pregnancy test (only applicable for women with childbearing potential)
  • Has known or suspected hypersensitivity or intolerance to melphalan, dexamethasone, boron, mannitol, or heparin, if an indwelling catheter is used
  • Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
  • History of hypotension or has decreased blood pressure (sitting systolic blood pressure \[SBP\] \<= 100 mmHg and/or sitting diastolic blood pressure \[DBP\] \<= 60 mmHg)
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Department of Haematology B, Aalborg Hospital, University of Aarhus

Aalborg, 9000, Denmark

Location

Dept. of Haematology, Århus University Hospital

Aarhus, 8000, Denmark

Location

Department of Haematology, Herlev University Hospital

Herlev, 2730, Denmark

Location

Department of Haematology X, Odense University Hospital

Odense, 5000, Denmark

Location

Hematologisk seksjon, med avd, Haukeland Universitetssykehus

Bergen, N-5021, Norway

Location

Department of Hematology, Rikshospitalet

Oslo, Norway

Location

Hematologisk seksjon, St.Olav Hospital

Trondheim, N-7006, Norway

Location

Department of Hematology, Sahlgrenska Sjukhuset

Gothenburg, Sweden

Location

University Hospital Lund

Lund, SE-221 85, Sweden

Location

MeSH Terms

Conditions

Multiple MyelomaRecurrence

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Peter Gimsing, M.D.

    Department of Haematology, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 27, 2007

Study Start

July 1, 2007

Primary Completion

June 1, 2009

Study Completion

September 1, 2010

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

DK(4)SE(2)NO(3)