NCT00652041

Brief Summary

Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfalan and Prednisone (V-MP) (patients \> 75 years) or Bortezomib and Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients \<= 75 years) follow by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients with refractary or relapse multiple myeloma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_4 multiple-myeloma

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

5 active sites

Status
completed

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

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 19, 2011

Status Verified

September 1, 2011

Enrollment Period

3 years

First QC Date

March 31, 2008

Last Update Submit

September 16, 2011

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaRelapsedRefractary

Outcome Measures

Primary Outcomes (1)

  • Efficacy of a sequential scheme treatment with Bortezomib, Melfalan,Prednisone (V-MP) or Bortezomib, Adriamycine, Melfalan,Prednisone (VAMP) followed by Thalidomide, Cyclophosphamide and Dexamethasone (TaCyDex) in relapsed or refractory MM patients

    1 year

Secondary Outcomes (2)

  • Evaluate the response type in function to different initial situation (primary resistance, relapse, progression)

    1 year

  • To analyze the response duration

    2 years

Study Arms (1)

1

EXPERIMENTAL

Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles

Drug: BortezomibDrug: Thalidomide

Interventions

BortezomibDRUG

Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4 and Prednisone, 60 mg/m2 oral, days 1 to 4

1
ThalidomideDRUG

Thalidomide, day 1 cycle 1, 100 mg/24 h. oral, in combination with cyclophosphamide and dexamethasone. If toxicity is \<Grade 2, dose should be increased to 200 mg/24 h. in day 15

1

Eligibility Criteria

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

You may qualify if:

  • Patients with refractary or relapsed multiple myeloma
  • ECOG ≤ 3
  • Life expectancy \> 3 months
  • Neutrophils account ≥ 0.5 X 10\^9/L, platelets ≥ 30 X 10\^9/L.
  • Transaminases \<3 times upper normal limit, bilirubin \< 2 times upper normal limit
  • Age \> 18 years
  • Time after last chemotherapy or radiotherapy \> 1 month or time after transplantation \> 2 months.
  • No possible other actual treatment
  • Written consent form

You may not qualify if:

  • Candidate to second transplantation
  • No following criteria
  • Other neoplasties
  • Peripheral neuropathy \> Grade 2.
  • Previous ileus paralytic
  • Hepatic failure
  • No controlled infection
  • No controlled high calcium levels
  • Any organic insufficiency that no permit follow the correct treatment
  • Pregnancy, breast feeding or fertility without anticonceptive method
  • Any psychological, social and/or familiar event that no permit follow the correct treatment
  • Diabetes mellitus not controled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Morales Messeguer

Murcia, Spain

Location

Hospital Virgen de la Vega

Murcia, Spain

Location

Hospital de la Diputación de Navarra

Navarra, Spain

Location

Hospital Clínico de Salamanca

Salamanca, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Related Links

MeSH Terms

Conditions

Multiple MyelomaRecurrence

Interventions

BortezomibThalidomide

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 CompoundsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2008

First Posted

April 3, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

September 19, 2011

Record last verified: 2011-09

Locations

ES(5)