Summary

for people ages 18-79 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

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.

Official 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

Keywords

Multiple Myeloma Neoplasms, Plasma Cell Neoplasm, Residual Lenalidomide Antibodies, Monoclonal Daratumumab Daratumumab + Lenalidomide

Eligibility

You can join if…

Open to people ages 18-79

  • Have newly diagnosed multiple myeloma with a history of 4 to 8 total cycles of induction with or without consolidation therapy and have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT): (a) for participants who have not received consolidation therapy, the participant must be 60 to 100 days post-transplant at the time of randomization; and (b) for participants treated with consolidation therapy, the participant must be within 60 days of the last dose of consolidation therapy at the time 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

You CAN'T join if...

  • 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 (<) 50 percent (%) of predicted normal
  • 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)

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • UCLA David Geffen School of Medicine not yet accepting patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT03901963
Phase
Phase 3
Study Type
Interventional
Last Updated