A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone with Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 569

Inclusion Criteria

1. Subject must have documented multiple myeloma as defined by the
criteria below:
? Monoclonal plasma cells in the bone marrow =10% at some point in their disease history or presence of a biopsy proven plasmacytoma.
? Measurable disease as defined by any of the following:
- 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 without measurable disease in the
serum or the urine: Serum immunoglobulin free light chain =10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
2. Subject must have received at least 1 prior line of therapy for multiple myeloma.
3. Subject must have achieved a response (PR or better based on investigator's determination of response by the IMWG criteria) to at least one prior regimen.
4. Subject must have documented evidence of progressive disease (PD) based on investigator's determination of response by the IMWG criteria on or after their last regimen.
5. Subject must have an ECOG Performance Status score of 0, 1, or 2.
Please refer to protocol for complete overview of inclusion criteria.
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 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

Exclusion Criteria

1. Subject has received daratumumab or other anti-CD38 therapies previously.
2. Subject's disease shows evidence of refractoriness or intolerance to lenalidomide.
3.Subject has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer,before the date of randomization.The only exception is emergency use of a
short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum 4 days) before treatment. 4.Subject has received ASCT within 12 weeks before the date of randomization,or the subject has previously received an allogenic stem cell transplant (regardless of timing)
5.Subjects planning to undergo a stem cell transplant prior to progression of disease on this study,ie, these subjects should not be enrolled in order to reduce disease burden prior to transplant
6.Subject has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)
7. Subject has known meningeal involvement of multiple myeloma
8.Subject has any of the following laboratory test results during the Screening Phase:
-Absolute neutrophil count =1.0 × 109/L
- Hemoglobin level =7.5 g/dL (=5 mmol/L) (it is not permissible to transfuse a subject to reach this level)
- Platelet count <75 × 109/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells; otherwise platelet count <50 ×109/L (it is not permissible to transfuse a subject to reach this level)
-Aspartate aminotransferase (AST)or alanine aminotransferase level (ALT) =2.5 times the upper limit of normal (ULN)
-Alkaline phosphatase level =2.5 × ULN
-Total bilirubin level =1.5 × ULN,(except for Gilbert Syndrome: direct bilirubin 1.5 ×ULN)
-Creatinine clearance <30 mL/min (for lenalidomide dose adjustment for
subjects with creatinine clearance 30-60 mL/min, please see Section 6.5).Calculated creatinine clearance may be calculated using the Cockcroft-Gault formula, Modification of Diet in Renal Disease (MDRD),or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (see Attachment 3)
- Corrected Serum calcium >14.0 mg/dL (>3.5 mmol/L) or free ionized calcium >6.5 mg/dL (>1.6 mmol/L).
9. Subject has 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.
Please refer to protocol for complete overview of exclusion criteria.

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

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