Clinical Trial 20141

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03901963

Phase: Phase III
Principal Investigator: Shain, Kenneth

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Overview

Study Title

A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

Summary

The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation flow (NGF) or next generation sequencing (NGS) following high-dose therapy (HDT) and autologous stem cell transplant (ASCT), with or without consolidation therapy.

Objective

To evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-CD38 treatment naïve patients with newly diagnosed multiple myeloma who are MRD positive as determined by next generation flow (NGF) or next generation sequencing (NGS) following high-dose therapy (HDT) and autologous stem cell transplant (ASCT), with or without consolidation therapy.

Treatments

Therapies

Therapy (NOS)

Medications

CC-5013 (Lenalidomide); Daratumumab (Darzalex); Lenalidomide (Revlimid)

Inclusion Criteria

Have newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy. Have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT); within 12 months of the start of induction therapy, and are within 6 months of ASCT on the date of randomization

Must have a very good partial response (VGPR) or better response assessed per International Myeloma Working Group (IMWG) 2016 criteria at the time of randomization

Have archived bone marrow biopsy samples collected before induction treatment (that is, at diagnosis) or before transplant (for example, at the end of induction). Archived bone marrow samples will be used for calibration of myeloma clonal cells to facilitate assessment of primary end point by next generation sequencing (NGS). Any one of the following archived samples are required: (a) Greater than 1 milliliter (mL) viable frozen bone marrow aspirated aliquot (preferred) collected in an ethylenediaminetetra-acetic acid (EDTA) tube, frozen, and stored at a temperature of −80 centigrade (°C), or; (b) Non-decalcified diagnostic bone marrow tissue for minimal residual disease (MRD) assessment: (i) 5 slides, 5 micrometer each, of non-decalcified bone marrow, or (ii) 5 slides, 5 micrometer each, bone marrow aspirate smear

Must have residual disease as defined by detectable MRD by next generation flow (NGF) assay

Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

Exclusion Criteria

Have peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5

Have any prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, and concurrence by the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)

Have had prior treatment/therapy with: (a) Anti-cluster of differentiation 38 (CD38) antibody at any time, (b) Radiation within 14 days of randomization, or (c) Plasmapheresis within 28 days of randomization

Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma

Have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (> Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification

Have any of the following: (a) Seropositive for human immunodeficiency virus (HIV); (b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR; (c) Seropositive for hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-RNA quantitation positive), except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy)

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