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Phase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in patients in 1st relapse or primary refractory after first line therapy for Multiple Myeloma.


- candidate number3909
- NTR NumberNTR1440
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-sep-2008
- Secondary IDs2007-002533-37 EudraCT nummer 
- Public TitlePhase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in patients in 1st relapse or primary refractory after first line therapy for Multiple Myeloma.
- Scientific TitlePhase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in patients in 1st relapse or primary refractory after first line therapy for Multiple Myeloma.
- ACRONYMHOVON 86 MM
- hypothesisPhase II part:
- Null hypothesis (H0):
(s)CR+VGPR rate = 15%
- Alternative hypothesis (H1):
(s)CR+VGPR rate = 30%
- Healt Condition(s) or Problem(s) studiedMultiple myeloma (Kahler's disease), Relapse
- Inclusion criteria1. Multiple Myeloma Salmon/Durie stage II/III A+B
2. Primary refractory to or first relapse after previous objective response (PR, VGPR, CR) on standard first-line treatment
3. Age 60 85 years inclusive
4. Not a candidate for high-dose therapy
5. Measurable disease, i.e., serum M-component (>10 g/l), or urinary light-chain excretion (>200mg/24h),or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l or proven plasmacytoma by biopsy
6. Able and/or willing to use adequate contraceptives (especially male patients)
7. Written informed consent
- Exclusion criteria1. Prior therapy with Bortezomib or Lenalidomide
2. History of allergic reaction attributable to compounds containing boron or mannitol
3. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
4. AL amyloidosis
5. Uncontrolled or severe cardiovascular disease
6. Impaired hepatic or renal function
7. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.)
8. Known HIV positivity
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 15-sep-2008
- planned closingdate15-sep-2014
- Target number of participants72
- InterventionsDuring the phase I part of the study, the MTD and RDL of Bortezomib and Lenalidomide with Dexamethasone will be determined according to a slightly modified `3 + 3 dose-escalation scheme, as illustrated in the figure below. A maximum of 4 dose levels will be evaluated.

When the phase I part has established the RDL of Bortezomib and Lenalidomide for the phase II study, all further included patients will be treated with Bortezomib and Lenalidomide at the RDL, combined with Dexamethasone.
- Primary outcomePhase I Primary endpoint
- Dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II dose (RDL) of Bortezomib and of Lenalidomide when combined with Dexamethasone.

Phase II Primary endpoint
- (s)CR+VGPR rate. In order for patients to be considered as a success for the primary endpoint, a VGPR or (s)CR must be documented according to criteria in appendix B. All other patients will be considered as not having achieved at least a VGPR. In this analysis we will consider the best response obtained during induction/consolidation chemotherapy.
- Secondary outcomePhase I Secondary endpoint
- Toxicity, especially myelosuppression, polyneuropathy and thrombosis

Phase II Secondary endpoints
- Overall Response
- Improvement of response due to maintenance treatment
- Toxicity, especially myelosuppression, polyneuropathy and thrombosis
- Progression free survival (PFS; i.e. time from registration to progression or death from any cause, whichever comes first)
- Overall survival measured from registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive
- PFS calculated from start of maintenance treatment
- OS calculated from start of maintenance treatment
- Timepoints- At entry
- After each induction cycle (Expected duration of induction is 6 - 7 months.)
- During maintenance and follow up: every 2 months. (All patients will be followed until 5 years after registration or, for patiens who are still on maintenance at that moment, until completion of maintenance therapy )
- Trial web sitehttp://www.hovon.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. P. Sonneveld
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P. Sonneveld
- Sponsor/Initiator Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Amgen, Dutch Cancer Society, Roche Nederland BV, Johnson&Johnson-Orthobiotech, Novartis, Celgene
- PublicationsN/A
- Brief summaryStudy phase: Phase I - II
Study objective:
Evaluation of the effect of Bortezomib combined with Lenalidomide in addition to Dexamethasone for induction and the effect of Lenalidomide alone for maintenance treatment

Patient population:
Patients with multiple myeloma, in 1st relapse or refractory after first line therapy, Salmon & Durie stage II or III, age 60-85 years inclusive

Study design:
Prospective, multicenter Duration of treatment: Expected duration of induction is 6 - 7 months. Maintenance therapy with Lenalidomide will be given until relapse/progression. All patients will be followed until 5 years after registration or, for patiens who are still on maintenance at that moment, until completion of maintenance therapy
- Main changes (audit trail)
- RECORD3-sep-2008 - 22-okt-2012


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