A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy

Phase 3

Completed

• Conditions: bone marrow cancer; Kahler disease; 10018849; 10027656

• Registration Number: NL-OMON54750
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 13

Inclusion Criteria

Participant must have documented multiple myeloma and measurable disease
defined as: 1) monoclonal plasma cells in the bone marrow greater than or equal
to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma; 2)
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 (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, - Man, who is sexually active with a woman of child-bearing
potential and has not had a 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 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] <60% of predicted normal), persistent asthma, or a history of asthma
within the last 2 years (intermittent 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is PFS, which is defined as the duration from the date of<br /><br>randomization to either progressive disease, or death, whichever occurs first.<br /><br>Disease progression will be determined according to the IMWG criteria.</p><br>