Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone

Korábbi kezelés

• Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies.
• Previous treatment according to the ICARIA schema with pomalidomide or IKEMA schema with carfilzomib
• Allogenic hematopoietic cell transplant (HCT, regardless of timing).
• Planned to undergo an hematopoietic cell transplant prior to progression of disease ie, these patients should not be enrolled in order to reduce disease burden prior to transplant.
• Any concurrent medical condition or disease (e.g., active systemic infection) that is likely to interfere with study procedures or results, or that, in the opinion, of the Investigator would constitute a hazard by participating in this study.

Más betegség

• History of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator is considered cured with minimal risk of recurrence within 3 years).
• Uncontrolled chronic obstructive pulmonary disease (COPD)
• Clinically significant cardiac disease.
• Seropositive for hepatitis B with positive PCR
• Seropositive for human immunodeficiency virus (HIV) or hepatitis C

Laborértékek

• Plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.

Egyéb

• Contraindications to investigational medicinal products or auxiliary medicinal product
• Known MM meningeal Involvement.
• Lactation
• Participation to another interventional clinical trial
• Inability to give written informed consent

• Adult patients (≥18 years old)
• Documented MM in relapse according to standard criteria.
• All patients must have received between 1 to 3 prior therapies for MM (a prior therapy is defined as 2 or more cycles of therapy given as a MM treatment plan)
  • Eligible for one of the following antibody-based approved combinations:
  • ICARIA schema: isatuximab, pomalidomide and dexamethasone.
  • IKEMA schema: isatuximab, carfilzomib and dexamethasone
• Subject must have achieved a response (PR or better) to the prior regimen.
• ECOG Performance Status score of 0, 1, or 2.
• For subjects experiencing toxicities resulting from previous therapy (including peripheral neuropathy), the toxicities must have been resolved or stabilized.
• Signed informed consent