Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants with Previously Untreated Multiple Myeloma
- Conditions
- Multiple myelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002273-11-IT
- Lead Sponsor
- JANSSEN CILAG INTERNATIONAL NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 730
-Participant must have documented multiple myeloma satisfying the CRAB (calcium elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma and measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma
(serum monoclonal paraprotein [Mprotein] level >=1.0 gram/deciliter [g/dL] or urine Mprotein level >=200 milligram[mg]/24 hours[hrs]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum Mprotein level >=0.5 g/dL or urine Mprotein level >=200 mg/24 hrs); or (c) light chain multiple myeloma without measurable disease in serum or urine (serum immunoglobulin free light chain >=10 mg/dL and
abnormal serum immunoglobulin kappa lambda free light chain ratio)
-Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
-Participants who are newly diagnosed and not considered for highdose chemotherapy due to: being age >=65 years; or participants less than
(<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on
tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required before randomization
-Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and must continue for 4 months after the last dose of daratumumab
-Man, who is sexually active with a woman of childbearing potential potential must agree to use a latex or synthetic condom, even if he had a
successful vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator, and must also agree
to not donate sperm during the study and for 4 weeks after last dose of lenalidomide and 4 months after last dose of daratumumab
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 693
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37
- Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum Mprotein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the Mprotein), or smoldering multiple myeloma
(asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage)
- Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
- Participant 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 and carcinoma in situ of the cervix, or malignancy 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)
- Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment
-Participant has had radiation therapy within 14 days of randomization
-Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second [FEV1] <50% of predicted normal), persistent asthma, or a history of
asthma within the last 2 years (controlled intermittent asthma or controlled mild persistent asthma is allowed)
-Participants with known or suspected COPD or asthma must have a FEV1 test during Screening
-Participant is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have active hepatitis B or hepatitis C
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