Ensayos clínicos

Inclusion Criteria:

• Subject is newly diagnosed and has symptomatic Multiple Myeloma (MM) prior to initiating induction anti-myeloma therapy.
• Subject is ≥ 18 years of age at the time of initial diagnosis of Multiple Myeloma (MM).
• Subject has measurable disease at initial diagnosis by -M-protein and/or -Light chain Multiple Myeloma (MM) without measurable disease in the serum or urine.
• Subject has high-risk MM at the time of initial diagnosis of Multiple Myeloma (MM) per R-ISS Stage III as defined by IMWG:
  • ISS Stage III and cytogenetic abnormalities with t(4; 14) and/or del(17p) and/or t(14:16) by iFISH; or
  • ISS Stage III and serum LDH > ULN.
• Subject has Eastern Cooperative Oncology Group performance ≤ 1.
• Subjects has received ≤ to 3 cycles of the following induction anti-myeloma therapy prior to enrollment:
  • Cycle 1: one of the following regimens (RVd, KRd, CyBorD, D-RVd and D-KRd);
  • Cycle 2 to Cycle 3: either KRd or RVd (Cycle 3 must be without dexamethasone). 

Exclusion Criteria:

• Subject has non-secretory Multiple Myeloma (MM) during Screening.
• Subject received any treatments for Multiple Myeloma (MM) other than up to 3 cycles of induction therapy per protocol.
• Subject has any of the following laboratory abnormalities:
  • Absolute neutrophil count < 1,000/μL;
  • Platelet count < 50,000 mm^3;
  • Hemoglobin < 8 g/dL (< 4.9 mmol/L);
  • Serum creatinine clearance < 45 mL/min;
  • Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L);
  • Serum aspartate aminotransferase or alanine aminotransferase > 2.5 × upper limit of normal;
  • Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome;
  • INR or aPTT > 1.5 × ULN.
• Subject has history or presence of clinically significant central nervous system (CNS) pathology.
• Subjects has high risk for developing deep vein thrombosis or pulmonary embolus and are unable or unwilling to undergo anti-thrombotic therapy.
• Subject has peripheral neuropathy of > Grade 2 severity according to the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 with bortezomib based induction regimen.
• Subjects has moderate or severe pulmonary hypertension.
• Subject has intolerance to components of induction regimen (KRd or RVd) or has any contraindication to one or the other drug.
• Subject has not recovered from induction therapy-related toxicities (non-hematologic) to < grade 1 CTCAE at the time of screening.
• Subject has prior history of deep vein thrombosis or pulmonary embolus (PE) within 6 months of starting study treatment.
• Subject has cardiac conditions such as:
  • Echocardiogram or multi gated acquisition assessment of left ventricular ejection fraction < 45%;
  • Subject has a history of clinically significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormalities.
• Subject has Pulmonary conditions such as:
  • Subject has known chronic obstructive pulmonary with a forced expiratory vol in 1 sec 50% of predicted normal;
  • Inadequate pulmonary function defined as oxygen saturation < 92 % on room air.
• Subject needs ongoing treatment with chronic immunosuppressants.
• Subject has history of primary immunodeficiency.
• Subject is seropositive for human immunodeficiency virus, chronic or active hepatitis B or active hepatitis A or C.