Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma

1. Adult male or female participants 18 years of age or older with a confirmed diagnosis of symptomatic multiple myeloma (MM) according to standard criteria.

1. Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic MM either currently or at the time of initial diagnosis, according to standard criteria, and relapsed and/or refractory disease after 1 to 3 lines of prior therapy. A participant is considered to have refractory disease if disease progression occurred during the treatment period or within 60 days of receiving the last dose of a given therapy. A line of therapy is defined as 1 or more cycles of a single-agent or combination therapy or a sequence of planned treatments such as induction therapy followed by autologous stem cell transplantation (ASCT) and then maintenance therapy.

2. No evidence of graft-versus-host disease for participants who have undergone prior allogeneic stem cell transplantation.

In addition, all participants (NDMM and RRMM) must meet all of the remaining criteria:

1. Participants must have measurable disease defined by at least 1 of the following 3 measurements:

* Serum M-protein ≥ 1 g/dL (≥ 10 g/L).

* Urine M-protein ≥ 200 mg/24 hours.

* Serum free light chain assay: involved free light chain level ≥ 10 mg/dL (≥ 100 mg/L), provided that the serum free light chain ratio is abnormal.

2. Participants must meet all of the following clinical laboratory criteria:

* Absolute neutrophil count (ANC) ≥ 1000/mm\^3 and platelet count ≥ 75,000/mm\^3. Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days prior to administration of the study drug.

* Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN).

* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.

* Calculated creatinine clearance (CrCL) ≥ 30 mL/min.

3. Eastern Cooperative Oncology Group performance status of 0, 1, or 2.

4. Female participants who:

* are postmenopausal for at least 1 year before the screening visit, or

* are surgically sterile, or

* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, or

* agree to practice true abstinence over the period previously described, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[ie, calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.), and

* adhere to any treatment-specific pregnancy prevention guidelines for cyclophosphamide and dexamethasone.

5. Male participants, even if surgically sterilized (ie, status post-vasectomy), who:

* agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, or

* agree to practice true abstinence over the period previously described, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods for the female partner\] and withdrawal are not acceptable methods of contraception.), and

* adhere to any treatment-specific pregnancy prevention guidelines for cyclophosphamide and dexamethasone.

6. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.

7. Suitable venous access for the study-required blood sampling.

8. Is willing and able to adhere to the study visit schedule and other protocol requirements.

Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma

What this study is about

Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma

What this study is about