NCT02155634
Withdrawn
Phase 3
Phase 3b, Randomized Trial of Continuous Revlimid® (Lenalidomide) Therapy Versus Observation Following Induction Therapy That Does Not Include Revlimid, Pomalyst® or Thalomid® in Newly Diagnosed Multiple Myeloma
ConditionsMultiple MyelomaNeoplasmsPlasma CellsParaproteinemiasBlood Protein DisordersHematologic DiseasesTherapeutic Uses
InterventionsLenalidomide
DrugsLenalidomide
Overview
- Phase
- Phase 3
- Intervention
- Lenalidomide
- Conditions
- Multiple Myeloma
- Sponsor
- Celgene
- Primary Endpoint
- Progression free survival (PFS)
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to see how long lenalidomide therapy can maintain or improve the disease response obtained after induction therapy that does not include lenalidomide, pomalidomide or thalidomide; and consequently reduce worsening of disease and to evaluate the activity of lenalidomide. Patients will receive lenalidomide or be under observation. All patients will attend regular clinic visits to evaluate their disease and health. Patients will have the option to participate in additional biomarker correlative studies in addition to their participation in the main study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: Related to initial diagnosis and prior induction
- •Previously untreated and symptomatic multiple myeloma (MM).
- •MM diagnosis meeting all 3 diagnostic criteria of (1) monoclonal plasma cells in the bone marrow ≥ 10% and/or presence of a biopsy-proven, plasmacytoma, (2) monoclonal protein in the serum and/or urine, and (3) at least one criteria of hypercalcemia, renal failure, anemia or bone disease.
- •Measurable disease by protein electrophoresis analyses.
- •All subjects must be treated with a minimum of 6 cycles (unless subject achieved a complete response prior to 6 cycles),and a maximum of 12 cycles of induction without lenalidomide (LEN), pomalidomide (POM) or thalidomide (THAL). Subject must have achieved at least stable disease (SD) as best overall response and maintained SD or better throughout the induction until screening. Subjects who plateau must have at least 2 cycles at best response prior to randomization.
- •Subjects must have cytogenetic (e.g.:17 p deletion, and 4;14 translocation), β-2 microglobulin and serum albumin (ISS Stage) results from their initial diagnosis available at the time of screening.
- •Related to the subject
- •Must understand and voluntarily sign the informed consent document (ICD) prior to the conduct of any study related assessments/procedures,
- •Age ≥ 65 years: if \< 65 years of age, the subject must be non eligible for or decline stem cell transplant,
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2,
Exclusion Criteria
- •The presence of any of the following will exclude the subject from the study enrollment:
- •Previous treatment with anti-myeloma therapy other than the required 6-12 cycles of induction without LEN, POM or THAL (does not include local radiotherapy, bisphosphonates, or a single short course of steroid \[ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization\]).
- •Subjects who did not achieve SD or better after getting at least 6 cycles of induction are not eligible.
- •Non-secretary MM.
- •Prior therapy with LEN, POM, THAL or Melphalan. Subjects who received investigational agents are also excluded.
- •Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •Pregnant or lactating females.
- •Any of the following laboratory abnormalities:
- •Absolute Neutrophil Count (ANC) \< 1,000/µL (1.0 x 109/L)
- •Untransfused platelet count \< 50,000 cells/µL (50 x 109/L)
Arms & Interventions
Lenalidomide
Lenalidomide maintenance given until disease progression. Long term follow-up 5 years post last patient randomized.
Intervention: Lenalidomide
Outcomes
Primary Outcomes
Progression free survival (PFS)
Time Frame: Approximately 36 months.
Time from randomization to the documentation of disease progression
Secondary Outcomes
- Safety(Approximate 6.5 years)
- Response Rate(Approximately 36 months)
- Time to progression (TTP)(Approximately 36 months)
- Overall survival (OS)(Approximate 6.5 years)
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