Overview
Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2026-01-31
2026-01-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janssen Research & Development, LLCTreatments:
Antibodies, MonoclonalBB 1101
Daratumumab
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide
Criteria
Inclusion Criteria:- 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
[M-protein] level >=1.0 gram/deciliter [g/dL] or urine M-protein level >=200
milligram[mg]/24 hours[hrs]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum
M-protein level >=0.5 g/dL or urine M-protein 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 high-dose 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 3 months after the last dose of daratumumab
- Man, who is sexually active with a woman of child-bearing 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
Exclusion Criteria:
- Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of
undetermined significance (presence of serum M-protein <3 g/dL; absence of lytic bone
lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), 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 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 must have a FEV1 test during Screening
- Participant is known to be seropositive for human immunodeficiency virus (HIV) or
hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg] or
antibodies to hepatitis B surface and core antigens [anti-HBs and anti-HBc,
respectively]) or hepatitis C (anti-HCV antibody positive or HCV-ribonucleic acid
[RNA] quantitation positive)