Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma - Full Text View

Purpose

The clinical trial is to evaluate the efficacy of single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200 mg/m2 followed by thalidomide maintenance in patients with newly-diagnosed myeloma after receiving 4-6 cycles of induction chemotherapy consisting of vincristin,adriamycin and dexamethasone (VAD) or thalidomide/dexamethasone between 18 to 65 years.

Condition	Intervention	Phase
Multiple Myeloma	Procedure: Single ASCT with Thalidomide maintenance	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase III Study of Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Thalidomide Melphalan Melphalan hydrochloride

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:

response rate: CR/nCR/VGPR [ Time Frame: 6 months after auto-PBSCT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Study arm Single Autologous Stem Cell Transplantation Followed by Thalidomide maintenance after 4-6 cycles of standard VAD chemotherapy or Thalidomide/dexamethasone induction	Procedure: Single ASCT with Thalidomide maintenance Single Autologous Stem Cell Transplantation: conditioning with Melphalan 200mg/m2 (iv) Thalidomide maintenance: starting from D60 after transplantation at 100-200mg daily (Oral) Other Names: multiple myeloma melphalan thalidomie

Detailed Description:

This is an open label clinical trial to evaluate the efficacy of single autologous hematopoietic stem cell transplantation in newly diagnosed multiple myeloma patients. All patients will receive 4-6 cycles of induction therapy which includes VAD chemotherapy (vincristin, adriamycin and dexamethasone) or thalidomide/dexamethasone. After peripheral hematopoietic stem cell mobilization and apheresis, patients will receive a standard conditioning with melphalan 200mg/m2 followed by thalidomide maintenance therapy at 100-200mg orally daily starting from D+60 till disease progression or untolerable toxicity.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Man or woman between age 18-65 with newly diagnosed Multiple Myeloma for whom stem cell transplantation is considered appropriate
Measurable serum and/or urinary paraprotein
European Cooperative Oncology Group performance status 0-3
Serum bilirubin < 1.5x the upper limit of normal (ULN)
Serum alanine transaminase (ALT)/aspartate transaminase values < 2.5 x ULN
Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study

Exclusion criteria:

Woman of child bearing potential
Non-secretory MM
Serum creatinine > 400 Micromol/l after initial resuscitation
patients with previous Grade 2-4 peripheral neuropathy
Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or III-IV heart failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892346

Contacts

Contact: Jiong HU, M.D.	0086-21-64370045 ext 601818	hujiong@medmai.com.cn
Contact: Wei Tang, M.D.	0086-21-64370045 ext 601878	weiwei_tang@yahoo.com

Locations

China
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine	Recruiting
Shanghai, China, 200025
Contact: Jiong HU, M.D. 0086-64370045 ext 601818 hujiong@medmail.com.cn
Principal Investigator: Jiong HU, M.D.

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

Principal Investigator:

Jiong HU, M.D.

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

More Information

Publications:

Chang JE, Juckett MB, Callander NS, Kahl BS, Gangnon RE, Mitchell TL, Longo WL. Thalidomide maintenance following high-dose melphalan with autologous stem cell support in myeloma. Clin Lymphoma Myeloma. 2008 Jun;8(3):153-8.

Abdelkefi A, Ladeb S, Torjman L, Othman TB, Lakhal A, Romdhane NB, Omri HE, Elloumi M, Belaaj H, Jeddi R, Aissaouï L, Ksouri H, Hassen AB, Msadek F, Saad A, Hsaïri M, Boukef K, Amouri A, Louzir H, Dellagi K, Abdeladhim AB; Tunisian Multiple Myeloma Study Group. Single autologous stem-cell transplantation followed by maintenance therapy with thalidomide is superior to double autologous transplantation in multiple myeloma: results of a multicenter randomized clinical trial. Blood. 2008 Feb 15;111(4):1805-10. Epub 2007 Sep 17.

Harousseau JL, Moreau P. Evolving role of stem cell transplantation in multiple myeloma. Clin Lymphoma Myeloma. 2005 Sep;6(2):89-95. Review.

Spencer A, Prince HM, Roberts AW, Prosser IW, Bradstock KF, Coyle L, Gill DS, Horvath N, Reynolds J, Kennedy N. Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure. J Clin Oncol. 2009 Apr 10;27(11):1788-93. Epub 2009 Mar 9.

Kumar A, Kharfan-Dabaja MA, Glasmacher A, Djulbegovic B. Tandem versus single autologous hematopoietic cell transplantation for the treatment of multiple myeloma: a systematic review and meta-analysis. J Natl Cancer Inst. 2009 Jan 21;101(2):100-6. Epub 2009 Jan 13. Review.

Responsible Party:	Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT00892346 History of Changes
Other Study ID Numbers:	MHOPES-myeloma09
Study First Received:	May 1, 2009
Last Updated:	September 14, 2011
Health Authority:	China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:

autologous hematopoietic stem cell transplantation
maintenance

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
Melphalan

Thalidomide
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013