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

Multiple Myeloma Clinical Trial

Official title:

Phase III Study of Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00892346
• Other study ID #: MHOPES-myeloma09
• Status: Suspended
• Phase: Phase 3
• First received: May 1, 2009
• Last updated: May 9, 2016
• Start date: May 2009
• Est. completion date: December 2017

Study information

• Verified date: May 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Procedure:
• Single ASCT with Thalidomide maintenance
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)

Locations

Country	Name	City	State
China	Rui Jin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Retraction in: Abdelkefi A, Ladeb S, Torjman L, Ben Othman T, Lakhal A, Ben Romdhane N, Elloumi M, Jeddi R, Aissaouï L, Ben Hassen A, Msadek F, Saad A, Hsaïri M. Blood. 2009 Jun 11;113(24):6265. — View Citation

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. doi: 10.3816/CLM.2008.n.018. — View Citation

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

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. doi: 10.1093/jnci/djn439. Epub 2009 Jan 13. Review. — View Citation

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. doi: 10.1200/JCO.2008.18.8573. Epub 2009 Mar 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate: CR/nCR/VGPR		6 months after auto-PBSCT	No
Secondary	overall survival		3 years	Yes
Secondary	progression free survival		3 years	Yes
Secondary	toxicity		3 years	Yes