Frontline Therapy in de Novo Multiple Myeloma Patients Under 65 (NCT01206205) | Clinical Trial Compass
CompletedPhase 2
Frontline Therapy in de Novo Multiple Myeloma Patients Under 65
France31 participantsStarted 2009-08
Plain-language summary
The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after High Dose Therapy (HDT) with ASCT.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Patients diagnosed with multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
* Subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related organ damage
* Subjects must have measurable disease requiring systemic therapy.
* Male or female subject 18 years of age or older
* Karnofsky Performance Status score of ≥50% (Eastern Cooperative Oncology Group Performance Status score ≤2)
* Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
* Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to therapy. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (1 highly effective method and 1 additional effective method) used at the same time, beginning at least 4 weeks before initiation of Revlimid treatment. Women must also agree to ongoing pregnancy testing
* Men must agree to not father a child and agree to use a latex condom during therapy and for 4 weeks after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential.
Exclusion Criteria:
* Subjects must not have been treated previously wit…
What they're measuring
1
Evaluation of the best response after consolidation
Timeframe: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients