A phase III study of Pomalidomide and Dexamethasone with or without Pembrolizumab in refractory or relapsed and refractory Multiple Myeloma (rrMM).
- Conditions
- Patients with refractory or relapsed and refractory multiple myeloma (rrMM) who have failed at least 2 lines of prior treatment and have been previously exposed to an immunomodulatory drug (IMiDs) as lenalidomide or thalidomide and a proteasome inhibitor as bortezomib or carfilzomib.MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002509-13-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1.Must have undergone prior treatment with = 2 treatment lines of anti- myeloma therapy and must have failed their last line of treatment defined as documented disease progression during or within 60 days of completing their last anti-myeloma therapy (refractory to last line of treatment). Note: A planned treatment approach of induction therapy followed by autologous stem cell transplantation, followed by maintenance, is considered one line of therapy.
2.Prior anti-myeloma treatments must have included an IMiD (i.e lenalidomide or thalidomide) AND proteasome inhibitor (i.e. bortezomib, ixazomib or carfilzomib) alone or in combination and subject must have failed therapy with an IMiD OR proteasome inhibitor defined as one of the following:
•Refractory: Resistant to treatment due to lack of response while on therapy or documented progressive disease on or within 60 days of completing treatment with an IMiD and/or proteasome inhibitor OR
•Relapsed and refractory: In case of prior response [= partial response (PR)] to an IMiD or proteasome inhibitor, subjects must have relapsed within 6 months after stopping treatment with and IMiD and/or
proteasome inhibitor containing regimens
3.Confirmed diagnosis of active MM and measurable disease defined as:
•Serum monoclonal protein (M-protein) levels = 0.5 g/dL or
•Urine monoclonal protein (M-protein) levels =200 mg/24-hours or
•Subjects without measurable serum and urine M-protein levels, an
abnormal serum free light chain ratio (FLC ?/?) with involved FLC level =
100 mg/L. (Normal serum FLC ?/? value: 0.26 - 1.65)
4.Provide at screening archival (=60 days) or newly obtained bone marrow biopsy or aspirate material for disease assessment at the local institution. Subjects participating in the biomarker sub-study who signed the biomarker informed consent should be able to provide a newly obtained bone marrow aspirate for central analysis.
5.Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225
1.Subjects with oligo-secretory myeloma, smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström's macroglobulinemia, or any history of plasma cell leukemia.
2.History of repeated infections, primary amyloidosis, hyperviscosity or POEMS syndrome.
3.Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
4.Has had prior antimyeloma therapy including but not limited to dexamethasone, IMiDs, proteasome inhibitors, chemotherapy, or radiation therapy within 2 weeks prior to Study Day 1 who has not recovered (i.e. = Grade 1 or at baseline) from adverse events due to a previously administered agent.
5.Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years. (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease (GVHD).
6.Has received autologous stem cell transplant (auto-SCT) within 12 weeks before the first infusion or are planning for or are eligible for auto-SCT.
7.Has known hypersensitivity to thalidomide, lenalidomide or dexamethasone.
8.Has received previous therapy with pomalidomide.
9.Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.
10.Subjects with peripheral neuropathy = Grade 2.
11.Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
12.Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method