TitleA Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor: The APOLLO Study
Overview / Summary
Approximately 302 subjects will be randomized in a 1:1 ratio to receive either Dara + pomalidomide + dexamethasone (DaraPomDex) or pomalidomide + dexamethasone (PomDex). Subjects who already began treatment with Dara IV prior to Amendment 1 will have the option to switch to subcutaneous administration of daratumumab for the remainder of their participation in the study and they will be counted toward the total of 302 subjects. Treatment cycles have a duration of 28 days. Subjects will receive treatment until disease progression or unacceptable toxicity. Drug administration and follow-up visits will occur more frequently for early cycles (eg, weekly or bi-weekly).
The primary objective of this study is to compare progression free survival (PFS) between treatment arms.
Patient eligibility criteria
- Males and females at least 18 years of age.
- Voluntary signed informed consent form (ICF) before performance of any study-related procedure.
- Subject must have measurable disease of multiple myeloma as defined by the criteria below:
- IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours, or
- IgA, IgD, IgE, IgM multiple myeloma: Serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
- Light chain multiple myeloma, for subjects without measurable disease in the serum or urine: Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
- Subjects must have received prior anti-myeloma treatment. The prior treatment must have included both a proteasome inhibitor (PI-) and lenalidomide-containing regimens. The subject must have had a response (ie, partial response or better based on the investigator‟s determination of response as defined by the modified IMWG criteria) to prior therapy.
- Subjects must have documented evidence of progressive disease (PD) based on the investigator‟s determination of response as defined by the modified IMWG criteria on or after the last regimen.
- Subjects who received only 1 line of prior treatment must have demonstrated PD on or within 60 days of completion of the lenalidomide-containing regimen (ie, lenalidomide refractory).
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
- Women of childbearing potential (WOCBP) must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of the study drugs and one within 24 hours prior to the start of study drugs. Women must not be breastfeeding. WOCBP must agree to follow instructions for methods of contraception for 4 weeks before the start of treatment with study drugs, for the duration of treatment with study drugs, and for a total of 3 months after cessation of daratumumab treatment. Males who are sexually active with WOCBP must always use a latex or synthetic condom during any sexual contact with females of reproductive potential, even if they have undergone a successful vasectomy.