Multiple Myeloma Treated With Thalidomide Before Autotransplant or With Conventional Chemotherapy and as Consolidation/Maintenance Treatment in Young and Elderly Patients : 3 Randomized Studies. - Full Text View

Purpose

The aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone before autotransplant, and in elderly patients in combination with conventional chemotherapy and as consolidation/maintenance therapy in young and elderly patients at plateau-phase.

Condition	Intervention	Phase
Multiple Myeloma de Novo Treatment	Drug: Thalidomide, Dexamethasone Drug: Vincristin , Adriamycin, Dexamethasone = VAD Drug: Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal) Drug: melphalan, endoxan, dexamethasone (MCDex)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Multiple Myeloma Treatment With Thalidomide. Three Randomized Studies on Thalidomide as Induction Treatment Before Autotransplant (MY-TAG) or With a Conventional Chemotherapy (MY-DECT) and as Consolidation/Maintenance at Plateau Phase (MY-PLAT).

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Cyclophosphamide Thalidomide Melphalan Dexamethasone acetate Dexamethasone sodium phosphate Melphalan hydrochloride Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:

very good partial response rate (monclonal protein decrease of 90 % or more)at the end induction phase (MY-TAG and MY-DECT), progression free survival during consolidation/maintenance treatment (MY-PLAT) [ Time Frame: before autotransplant (MY-TAG), after 4 cycles (MY-DECT), every 6 months (MY-PLAT) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

partial response rate (> or = 50%), PFS and OS since diagnosis, safety thalidomide + chemotherapy [ Designated as safety issue: Yes ]

Study Start Date:	May 2003
Study Completion Date:	December 2009

Arms	Assigned Interventions
Experimental: thalidomide + dexamethasone Thalidomide 200 mg/d at bedtime + Dexamethasone 40 mg/d oral D1-D4 and D15-D18 for 2 first cycles, D1-D4 for the 3d cycle	Drug: Thalidomide, Dexamethasone Thalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles
Active Comparator: Vincristin, Adriamycin, Dexamethasone	Drug: Vincristin , Adriamycin, Dexamethasone = VAD Vincristin 0.4 mg/d continUous IV infusion D1-D4, Adriamycin 9 mg/m2 continuous IV infusion D1-D4, Dexamethasone 40 mg/d oral D1-D4 and D15-D18 for 2 first cycles, D1-D4 for the 3d cycle
Experimental: thalidomide, melphalan, endoxan, dexamethasone	Drug: Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal) Thalidomide : 200 mg/d at bedtime for 3 months , melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles
Active Comparator: melphalan, endoxan, dexamethasone (MCDex)	Drug: melphalan, endoxan, dexamethasone (MCDex) melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles
Experimental: Thalidomide, Dexamethasone	Drug: Thalidomide, Dexamethasone Thalidomide 200 mg/d on every other 3 months Dexamethasone 40 mg/d D1-D4, D30-D34,D60-D64, D90-D94
No Intervention: watch and wait

Detailed Description:

MY-TAG : Thalidomide as induction treatment before high dose therapy, in young patients MY-DECT : Thalidomide as induction treatment with conventional chemotherapy, in elderly patients MY-PLAT : Thalidomide and Dexamethasone at plateau-phase, after high dose therapy or conventional chemotherapy

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

for MY-TAG(auto-transplant): age 18-65, multiple myeloma Salmon-Durie stage II, stage III and symptomatic stage I (lytic bone lesion or a 25 % increase of monoclonal protein)
for MY-DECT (conventional chemotherapy) : qge 66-80, multiple myeloma Salmon-Durie stage II, stage III and symptomatic stage I (lytic bone lesion or a 25 % increase of monoclonal protein)
for MY-PLAT (maintenance at plateau-phase): patients treated in MY-TAG or MY-DECt with at least a minimal response (25 % decrease of M protein)3-6 months after autotransplant or last chemotherapy

Exclusion Criteria:

for MY-TAG : age 66 or more, smoldering stage I multiple myeloma, previous therapy, plasma cell leukemia,creatinine > 300 micromol/L, liver failure, anthracycline contra-indicated, thalidomide contra-indicated, corticosteroid contra-indicated
for MY-DECT : age < 66 or > 80, smoldering stage I multiple myeloma, previous therapy, plasma cell leukemia,creatinine > 300 micromol/L, liver failure, thalidomide contra-indicated, corticosteroid contra-indicated
for MY-PLAT : no response or progressive disease, randomization > 6 m since autotransplant or last chemotherapy, creatinine > 300 micromol/L, liver failure, thalidomide contra-indicated, corticosteroid contra-indicated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070862

Locations

France
CHU CAEN Dept of Hematology
Caen, France, 14033
CHU Henri Mondor
Creteil, France, 94010
CHU Saint Louis Dept of Hematology
Paris, France, 75475

Sponsors and Collaborators

University Hospital, Caen

Laphal

More Information

No publications provided

Responsible Party:	Margaret MACRO, MD, University hospital, Caen
ClinicalTrials.gov Identifier:	NCT01070862 History of Changes
Other Study ID Numbers:	020879
Study First Received:	February 17, 2010
Last Updated:	February 17, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:

multiple myeloma, treatment, first line

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide

Melphalan
Thalidomide
Dexamethasone
Doxorubicin
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on June 18, 2013

Multiple Myeloma Treated With Thalidomide Before Autotransplant or With Conventional Chemotherapy and as Consolidation/Maintenance Treatment in Young and Elderly Patients : 3 Randomized Studies. (MAG 2002)