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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001051-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Tampere University Hospital | OTHER |
| Turku University Hospital | OTHER_GOV |
| Oulu University Hospital |
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The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Cyclophosphamide plus filgrastim |
|
| B | Active Comparator | Filgrastim |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug |
| ||
| Filgrastim |
| Measure | Description | Time Frame |
|---|---|---|
| Immunophenotypic response | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | From date of inclusion until the date of first documented progression or date of death from any cause whatever come first assessed up to last patient 2 years on maintenance |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of pts collected with >/= 3 x 10e6/kg CD34+ with </= 2 apheresis after mobilization with CY 2g/m2 + filgrastim (group A) or filgrastim alone (group B) | Assessed up to 2 weeks from the start of mobilization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raija Silvennoinen, MD | Kuopio University Hospital, Kuopio, FI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Kuopio | Northern Savonia | 70200 | Finland | ||
| Tampere University Hospital |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| OTHER |
| Mikkeli Central Hospital | OTHER |
| Kymenlaakso Central Hospital Kotka Finland | OTHER |
| Jyväskylä Central Hospital | OTHER |
| Kanta-Häme Central Hospital | OTHER_GOV |
| Satakunta Central Hospital | OTHER |
| Kainuu Central Hospital, Kajaani | OTHER |
| Celgene Corporation | INDUSTRY |
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|
| Tampere |
| Pirkanmaa |
| 33100 |
| Finland |
| Kanta-Häme Central Hospital | Hämeenlinna | Finland |
| Helsinki University Hospital | Helsinki | Finland |
| Jyväskylä Central Finland Central Hospital | Jyväskylä | Finland |
| Kainuu Kajaani Central Hospital | Kajaani | Finland |
| Länsi-Pohja Central Hospital | Kemi | Finland |
| Kymenlaakso Central Hospital | Kotka | Finland |
| Mikkeli Southern-Savo Central Hospital | Mikkeli | Finland |
| Oulu University Hospital | Oulu | Finland |
| Satakunta Central Hospital | Pori | Finland |
| Turku University Central Hospital | Turku | Finland |
| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |