A phase III study to determine the role of a second autologous stem cell transplant as consolidation therapy in patients with relapsed multiple myeloma following prior high dose chemotherapy and autologous stem cell rescue

The Leeds Teaching Hospitals NHS Trust (UK)0 sites293 target enrollmentJanuary 26, 2007

Overview

2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24948586 results (added 10/04/2019) 2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/23298856 results (added 10/04/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26827659 results (added 10/04/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27374467 results (added 10/04/2019)

Registry

who.int

Start Date

January 26, 2007

End Date

November 30, 2016

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

The Leeds Teaching Hospitals NHS Trust (UK)

•Inclusion criteria amended as of 24/08/2007:
•Registration:
•1\. Diagnosed with symptomatic (including non\-secretory) Multiple Myeloma (MM) previously treated with standard chemotherapy and autologous transplantation
•2\. Requiring therapy for first Progressive Disease (PD) (where PD is determined according to the International uniform response criteria for myeloma. Patients previously immunofixation negative who are now immunofixation positive need to demonstrate a greater than 5 g/liter absolute increase in paraprotein to be eligible for inclusion)
•3\. Demonstrate PD requiring treatment at least 18 months from time of first transplant
•4\. Eastern Cooperative Oncology Group (ECOG) Performance Status 0\-2
•5\. Aged at least 18 years
•6\. Adequate full blood count within 14 days before registration:
•a. Platelet count greater than or equal to 50 x 109/L
•b. Absolute Neutrophil Count (ANC) greater than or equal to 1 x 109/L

•Exclusion criteria amended as of 24/08/2007:
•Registration:
•1\. Received therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange, or dexamethasone up to a maximum of 200 mg. (Radiotherapy since pervious transplant sufficient to alleviate or control pain of local invasion is permitted. Patients who have received hemi\-body radiation or similar since previous transplant will not be eligible)
•2\. ECOG Performance Status 3\-4
•3\. Greater than or equal to Grade 2 peripheral neuropathy within 14 days before registration
•4\. Known HIV or Hepatitis B/C seropositivity (testing is not required for the trial)
•5\. Use of any investigational drug within 4 weeks prior to registration, or scheduled to receive any investigational drug during the course of the study
•6\. Known resistance to combined bortezomib, doxorubicin and dexamethasone (PAD) therapy
•7\. Known history of allergy contributable to compounds containing boron or mannitol
•8\. Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient's participation in this study