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Completed

NCT Number: NCT01592370

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.

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Key information

Conditions

Non-Hodgkin's Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0045, Ghent, Belgium

Loading trial locations.

About this study

NOTE: Currently, this study is only open to nivolumab+daratumumab vs daratumumab monotherapy in multiple myeloma patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Have received at least 3 prior lines of therapy, including a proteasome inhibitor [PI] and an immunomodulatory agent [IMiD] OR have disease that is double refractory to a PI and IMiD
  • More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant)
  • Have detectable disease measured by a specific protein in your blood and/or urine
  • Must consent to bone marrow aspirate or biopsy.

Exclusion criteria

  • Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA 4, or anti-CD38 antibody, or allogeneic stem cell transplantation
  • Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen or Hepatitis C antibody positive (except if HCV-RNA negative), or history of active chronic hepatitis B or C
  • History of central nervous system involvement or symptoms suggestive of central nervous system involvement by multiple myeloma

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

Nivolumab

Biological

Administered by intravenous (IV) infusion

Other names: BMS-936558, Opdivo

Ipilimumab

Biological

Administered by IV infusion

Other names: Yervoy, BMS-734016, MDX010

Lirilumab

Biological

Administered by IV infusion

Other names: BMS-986015

Daratumumab

Biological

Administered by IV infusion

Other names: Darzalex

Pomalidomide

Drug

Administered PO

Other names: Pomalyst

Dexamethasone

Drug

Administered PO and by IV infusion

Other names: Intensol

Primary outcomes

  1. Number of Participants That Experienced Drug Related Grade 3-4 AEs

    Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

    Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.

  2. Number of Participants That Experienced Drug Related Grade 3-4 SAEs

    Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

    Number and percent of participants that experienced drug related Grade 3-4 SAEs occurring up to 100 days after the last dose of study drug.

  3. Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver

    Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

    Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.

  4. Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid

    Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

  5. Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

  6. Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

  7. Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology

    Time frame: approximately up to 4 years

  8. Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver

    Time frame: approximately up to 4 years

  9. Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid

    Time frame: approximately up to 4 years

Secondary outcomes

  1. Best Overall Response

    Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

    the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.

    Measured in Complete Response and Partial Response

  2. Best Overall Response - Multiple Myeloma Group

    Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

    the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.

  3. Duration of Response

    Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to approximately 37 months Nivo Liri: approximately up to 4 years 1 month

    the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.

    Measured in Complete Remission and Partial Remission

  4. Duration of Response - Multiple Myeloma Group

    Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

    the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.

    Measured in Complete Response and Partial Response

  5. Progression Free Survival

    Time frame: From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)

    Progression free survival (PFS) is defined as the time between date of randomization and date of progression or death, whichever occurs first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not progress or die were censored on the date of their last efficacy assessment.

  6. Progression Free Survival Rate

    Time frame: From randomization to the specified timepoints (up to 48 months)

    The percentage of participants remaining progression free at the specified timepoints (up to 48 Months)

  7. Overall Survival

    Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to3 years Nivo Liri: approximately up to 4 years 1 month

    The percentage of participants remaining alive. Median values are computed using Kaplan-Meier method

  8. Number of Participants With PD-L1 Expression

    Time frame: At baseline (prior to start of study treatment)

    Number of Participants with PD-L1 expression in the following categories

    • baseline PD-L1 expression ≥ 1%
    • baseline PD-L1 expression < 1%
    • without PD-L1 quantifiable at baseline

  9. Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score

    Time frame: From baseline (last measurement before start of study treatment) to last available measurement after start of study treatment (88 weeks for Nivo mono, 93 weeks for nivo+ipi, 25 weeks for nivo+liri)

    mSWAT is a scoring technique involving the direct assessment of the percentage of body-surface-area (BSA) affected by skin lesions.

    There are 12 body regions (each one assigned a different percentage of BSA). For each body region, the assigned BSA percentage is multiplied by a factor weighing the type and severity of lesion observed (patch= x1, plaque = x2, tumor= x4).

    The sum of the individual body region sub-scores is then summed to generate the final mSWAT score, which ranges from 0 (best outcome) to 400 (worst outcome).

  10. Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

    Time to MRD Negativity status in specific NGS and NGF sensitivity levels

  11. Objective Response Rate in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

  12. Duration of Response in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

  13. Progression Free Survival in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

  14. Cmax in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

    Maximum observed serum concentration

  15. Tmax in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

    Time of maximum observed serum concentration

  16. Cmin in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

    Serum concentration achieved at the end of dosing interval (trough concentration)

  17. AUC (0-T) in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

    Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration

  18. AUC (TAU) in the Nivolumab + Daratumumab Cohort

    Time frame: approximately up to 4 years

    Area under the concentration-time curve in one dosing interval

  19. End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort

    Time frame: Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days

    Serum concentration achieved at the end of study drug infusion

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Janssen, LP

Registry information

Official study title

Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies

Important dates

Study start
2012
Primary completion
2020
Study completion
2024
First posted
May 7, 2012
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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