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A Prospective Phase II Study to Assess Immunophenotypic Remission After 3-drug Induction Followed by Randomized Stem Cell Mobilization, Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

A Prospective Phase II Study to Assess Immunophenotypic Remission After 3-drug Induction Followed by Randomized Stem Cell Mobilization, Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma


Inclusion Criteria:



- written informed consent

- symptomatic, previously untreated International Stating System (ISS) 1-3 myeloma

- measurable disease

- WHO perf status 0-3

- eligible for ASCT

Exclusion Criteria:

- previously treated

- peripheral neuropathy gr >/= 2

- significant hepatic dysfunction

- severe cardiac dysfunction

- severe renal failure if not in dialysis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Immunophenotypic response

Outcome Description:

Response will be measured by International Myeloma Working Group (IMWG) guidelines, and if the response is stringent CR and immunophenotypic remission, those patients will be followed also by allele-spesific oligonucleotide-polymerase chain reaction assay (ASO-PCR) to find out molecular remission rate.

Outcome Time Frame:

Change from the start of induction treatment at 3 months, change from the start of induction at 6 months, at 9 months, at 12 months, at 16 months, at 20 months, at 24 moths

Safety Issue:

Yes

Authority:

Finland: Finnish Medicines Agency

Study ID:

KUH5101424

NCT ID:

NCT01790737

Start Date:

January 2013

Completion Date:

December 2017

Related Keywords:

  • Multiple Myeloma
  • myeloma, stem cell mobilization, autologous stem cell transplantation
  • induction treatment, maintenance treatment
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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