Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma (TaCyDexVMP7)
This study has been completed.
Sponsor:
PETHEMA Foundation
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00652041
First received: March 31, 2008
Last updated: September 16, 2011
Last verified: September 2011
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Purpose
Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfalan and Prednisone (V-MP) (patients > 75 years) or Bortezomib and Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients <= 75 years) follow by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients with refractary or relapse multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Bortezomib Drug: Thalidomide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Thalidomide
Prednisone
Melphalan
Dexamethasone acetate
Dexamethasone sodium phosphate
Melphalan hydrochloride
Bortezomib
U.S. FDA Resources
Further study details as provided by PETHEMA Foundation:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate the response type in function to different initial situation (primary resistance, relapse, progression) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To analyze the response duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2007 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles
|
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.
|
Detailed Description:
Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfalan and Prednisone (V-MP) (patients > 75 years) or Bortezomib and Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients <= 75 years) follow by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients with refractary or relapse multiple myeloma.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652041
Locations
| 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 | |
Sponsors and Collaborators
PETHEMA Foundation
More Information
Additional Information:
No publications provided
| Responsible Party: | Pethema |
| ClinicalTrials.gov Identifier: | NCT00652041 History of Changes |
| Other Study ID Numbers: | TaCyDexVMP7 |
| Study First Received: | March 31, 2008 |
| Last Updated: | September 16, 2011 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by PETHEMA Foundation:
|
Multiple Myeloma Relapsed Refractary |
Additional relevant MeSH terms:
|
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 Cyclophosphamide |
Melphalan Thalidomide Bortezomib Dexamethasone Prednisone Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on May 16, 2013