Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma - Full Text View

Sponsor:	PETHEMA Foundation
Information provided by:	PETHEMA Foundation
ClinicalTrials.gov Identifier:	NCT00652041

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Bortezomib Drug: Thalidomide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Thalidomide-Cyclophosphamide-Dexamethasone in Patients < 75 Years or Velcade-Melfalan-Prednisone (V-MP)/Thalidomide-Cyclophosphamide-Dexamethasone in Patients >75 Years, in Refractary or Relapsed Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Cyclophosphamide Thalidomide Prednisone Dexamethasone acetate Doxiproct plus Bortezomib Melphalan Sarcolysin Dexamethasone Sodium Phosphate Melphalan hydrochloride

U.S. FDA Resources

Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the response type in function to different initial situation (primary resistance, relapse, progression) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To analyze the response duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: Bortezomib 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 Drug: Thalidomide 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 Drug: Bortezomib Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4, Prednisone, 60 mg/m2 oral, days 1 to 4 and Adriamicine, 40 mg/m2 IV day 1 or Caelyx 30 mg/m2 IV day 1.

Arms

Assigned Interventions

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: Bortezomib

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

Drug: Thalidomide

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

Drug: Bortezomib

Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4, Prednisone, 60 mg/m2 oral, days 1 to 4 and Adriamicine, 40 mg/m2 IV day 1 or Caelyx 30 mg/m2 IV day 1.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652041

Locations

Spain
Hospital Clínico de Salamanca
Salamanca, Spain
Hospital Morales Messeguer
Murcia, Spain
Hospital Virgen de la Vega
Murcia, Spain
Hospital La Fe
Valencia, Spain
Hospital de la Diputación de Navarra
Navarra, Spain

Sponsors and Collaborators

PETHEMA Foundation

More Information

Additional Information:

Pethema Foundation web This link exits the ClinicalTrials.gov site

spanish hematology association This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pethema ( Pethema )
Study ID Numbers:	TaCyDexVMP7
Study First Received:	March 31, 2008
Last Updated:	May 11, 2009
ClinicalTrials.gov Identifier:	NCT00652041 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:

Multiple Myeloma
Relapsed
Refractary

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Angiogenesis Modulating Agents
Immunoproliferative Disorders
Immune System Diseases

Antineoplastic Agents, Hormonal
Hematologic Diseases
Glucocorticoids
Protease Inhibitors
Multiple Myeloma
Neoplasms
Leprostatic Agents
Melphalan
Immunologic Factors
Thalidomide
Blood Protein Disorders
Antineoplastic Agents
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders

ClinicalTrials.gov processed this record on February 08, 2010