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

Sponsored by:	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

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

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

U.S. FDA Resources

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

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

Contacts

Contact: San Miguel Jesús, Dr

923 291 515

ensayosclinicos@husa.sacyl.es

Locations

Spain
Hospital Clínico de Salamanca	Recruiting
Salamanca, Spain
Contact: San Miguel Jesús, Dr
Contact: Mateos Maria Victoria, Dr
Hospital Morales Messeguer	Recruiting
Murcia, Spain
Hospital Virgen de la Vega	Recruiting
Murcia, Spain
Hospital La Fe	Recruiting
Valencia, Spain
Hospital de la Diputación de Navarra	Recruiting
Navarra, Spain

Sponsors and Collaborators

PETHEMA Foundation

More Information

Pethema Foundation web This link exits the ClinicalTrials.gov site

spanish hematology association This link exits the ClinicalTrials.gov site

Responsible Party:	Pethema ( Pethema )
Study ID Numbers:	TaCyDexVMP7
Study First Received:	March 31, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00652041
Health Authority:	Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:

Multiple Myeloma
Relapsed
Refractary

Study placed in the following topic categories:

Dexamethasone
Melphalan
Prednisone
Immunoproliferative Disorders
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases

Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Doxorubicin
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Anti-Bacterial Agents
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents

Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Growth Substances
Gastrointestinal Agents
Enzyme Inhibitors
Angiogenesis Inhibitors
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Autonomic Agents
Myeloablative Agonists
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on January 16, 2009