The Efficacy and Safety of Pomalidomide and Bendamustine With Dexamethasone in Relapsed or Refrac… (NCT04762745) | Clinical Trial Compass
UnknownPhase 1/2
The Efficacy and Safety of Pomalidomide and Bendamustine With Dexamethasone in Relapsed or Refractory Multiple Myeloma
China56 participantsStarted 2021-02
Plain-language summary
To explore the efficacy and safety of pomalidomide and bendamustine with dexamethasone in relapsed or refractory multiple myeloma
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age of 18-75, no gender limitations.
* Ability of contraception during the experiment, no matter if they have suffered from infertility.
* Relapsed or refractory to prior lenalidomide or/and bortezomib(either in combination or sequential)therapy (i.e. history of progression on therapy or within 60 days after completion)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, life expectancy of more than 6 months.
* Measurable disease:
Serum M protein \> 10 g/L or Urine M protein ≥200 mg/24 hr or Elevated Free Light Chain per International Myeloma Working Group (IMWG) criteria, and abnormal ratio.
* Absolute neutrophil count (ANC) \>1.0 x 109/L or \>1.0 x 109/L due to granulocyte/macrophage colony stimulating factor (GCSF and GMCSF), or if \>50% marrow involvement, there is no limitations
* Platelet count \>50.0 x 109/L or if \>50% marrow involvement, there is no limitations.
* Total bilirubin ≤ 2.0mg/dL, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times the upper limit of normal.
* Serum creatinine ≤2.0 mg/dL or creatinine clearance ≥60ml/min.
* Agree to take anticoagulant drugs, included but not limited to aspirin.
* Agree to sign the informed consent form.
Exclusion Criteria:
* Patients with known sensitivity to pomalidomide or bendamustine or dexamethasone and their accessories.
* Patients with primary systemic amyloidosis or monoclonal gammopathy of undetermined significance or smoldering multiple …
What they're measuring
1
Overall response rate
Timeframe: At the end of Cycle 8 in Phase II (each cycle is 28 days)