Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma (TaCyDexVMP7)
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ClinicalTrials.gov Identifier: NCT00652041 |
Recruitment Status :
Completed
First Posted : April 3, 2008
Last Update Posted : September 19, 2011
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Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma | Drug: Bortezomib Drug: Thalidomide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Thalidomide-Cyclophosphamide-Dexamethasone in Patients < 75 Years or Velcade-Melfalan-Prednisone (V-MP)/Thalidomide-Cyclophosphamide-Dexamethasone in Patients >75 Years, in Refractary or Relapsed Multiple Myeloma |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
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Experimental: 1
Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles
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Drug: Bortezomib
Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4 and Prednisone, 60 mg/m2 oral, days 1 to 4 Drug: Thalidomide Thalidomide, day 1 cycle 1, 100 mg/24 h. oral, in combination with cyclophosphamide and dexamethasone. If toxicity is <Grade 2, dose should be increased to 200 mg/24 h. in day 15 Drug: Bortezomib Bortezomib, 1,3 mg/ m2 iv twice a week in combination with Melfalán 9 mg/m2 oral, days 1 to 4, Prednisone, 60 mg/m2 oral, days 1 to 4 and Adriamicine, 40 mg/m2 IV day 1 or Caelyx 30 mg/m2 IV day 1. |
- Efficacy of a sequential scheme treatment with Bortezomib, Melfalan,Prednisone (V-MP) or Bortezomib, Adriamycine, Melfalan,Prednisone (VAMP) followed by Thalidomide, Cyclophosphamide and Dexamethasone (TaCyDex) in relapsed or refractory MM patients [ Time Frame: 1 year ]
- Evaluate the response type in function to different initial situation (primary resistance, relapse, progression) [ Time Frame: 1 year ]
- To analyze the response duration [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with refractary or relapsed multiple myeloma
- ECOG ≤ 3
- Life expectancy > 3 months
- Neutrophils account ≥ 0.5 X 10^9/L, platelets ≥ 30 X 10^9/L.
- Transaminases <3 times upper normal limit, bilirubin < 2 times upper normal limit
- Age > 18 years
- Time after last chemotherapy or radiotherapy > 1 month or time after transplantation > 2 months.
- No possible other actual treatment
- Written consent form
Exclusion Criteria:
- Candidate to second transplantation
- No following criteria
- Other neoplasties
- Peripheral neuropathy > Grade 2.
- Previous ileus paralytic
- Hepatic failure
- No controlled infection
- No controlled high calcium levels
- Any organic insufficiency that no permit follow the correct treatment
- Pregnancy, breast feeding or fertility without anticonceptive method
- Any psychological, social and/or familiar event that no permit follow the correct treatment
- Diabetes mellitus not controled

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652041
Spain | |
Hospital Morales Messeguer | |
Murcia, Spain | |
Hospital Virgen de la Vega | |
Murcia, Spain | |
Hospital de la Diputación de Navarra | |
Navarra, Spain | |
Hospital Clínico de Salamanca | |
Salamanca, Spain | |
Hospital La Fe | |
Valencia, Spain |
Responsible Party: | Pethema |
ClinicalTrials.gov Identifier: | NCT00652041 |
Other Study ID Numbers: |
TaCyDexVMP7 |
First Posted: | April 3, 2008 Key Record Dates |
Last Update Posted: | September 19, 2011 |
Last Verified: | September 2011 |
Multiple Myeloma Relapsed Refractary |
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 |
Thalidomide Bortezomib Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |