An Investigational Immuno-Therapy study to determine the safety andeffectiveness of Nivolumab and Daratumumab in patients with MultipleMyeloma

Phase 1

• Conditions: Multiple myeloma (current protocol); MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001030-17-GR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-29
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified