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Trial record 1 of 1 for:    MEDI4736-MM-001
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A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02616640
First Posted: November 30, 2015
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
  Purpose
This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen.

Condition Intervention Phase
Multiple Myeloma Drug: Durvalumab Drug: Pomalidomide Drug: Dexamethasone Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IB Multicenter, Open-label Study To Determine The Recommended Dose And Regimen Of Durvalumab (MEDI4736) Either As Monotherapy or In Combination With Pomalidomide (POM) With Or Without Low-Dose Dexamethasone (DEX) In Subjects With Relapsed And Refractory Multiple Myeloma (RRMM)

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Dose-limiting Toxicities (DLTs) [ Time Frame: Approximately 1 month ]
    Number of participants with DLTs in the first cycle of treatment


Secondary Outcome Measures:
  • Adverse Events (AEs) [ Time Frame: Up to approximately 2 year ]
    Number of participants with adverse events

  • Overall response rate (ORR) [ Time Frame: Up to approximately 2 year ]
    Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria

  • Time to response (TTR) [ Time Frame: Up to approximately 2 year ]
    Time from first dose to the first documentation of response (Partial Response [PR] or greater)

  • Duration of response (DOR) [ Time Frame: Up to approximately 2 year ]
    Is defined as time from the earliest date of documented response (partial response (PR) or better) to the earliest date when disease progression was confirmed

  • Pharmacokinetics- Cmax [ Time Frame: Up to approximately 1 year ]
    Maximum observed concentration

  • Pharmacokinetics- AUC [ Time Frame: Up to approximately 1 year ]
    Area under the concentration-time curve

  • Pharmacokinetics- Tmax [ Time Frame: Up to approximately 1 year ]
    Time to maximum concentration

  • Pharmacokinetics- t1/2 [ Time Frame: Up to approximately 1 year ]
    Terminal elimination half-life

  • Pharmacokinetics- CL/F [ Time Frame: Up to approximately 1 year ]
    Apparent total body clearance

  • Pharmacokinetics- Vz/F [ Time Frame: Up to approximately 1 year ]
    Volume of distribution


Estimated Enrollment: 121
Actual Study Start Date: January 11, 2016
Estimated Study Completion Date: August 16, 2018
Estimated Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Durvalumab monotherapy
Intravenous (IV) durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle
Drug: Durvalumab
Other Name: MEDI4736
Experimental: Durvalumab + pomalidomide (POM)
IV durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle and Oral POM 4 mg/day on Days 1 to 21 of each 28-day treatment cycle
Drug: Durvalumab
Other Name: MEDI4736
Drug: Pomalidomide
Experimental: Durvalumab + pomalidomide (POM) + dexamethasone (dex)
IV durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle with Oral POM 4 mg/day on Days 1 to 21 of each 28-day treatment cycle and Oral dex 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of a 28-day cycle
Drug: Durvalumab
Other Name: MEDI4736
Drug: Pomalidomide Drug: Dexamethasone

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a confirmed diagnosis of active multiple myeloma and measurable disease.
  • Must have undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy
  • Must have failed last line of treatment (refractory to last line of treatment).
  • Must have achieved at least a stable disease (SD) for at least 1 cycle of treatment to at least 1 prior anti-myeloma regimen before developing Progressive disease (PD) (relapsed)
  • Prior anti-myeloma treatments must have included a lenalidomide AND proteasome inhibitor alone or in combination.
  • Has performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  • The extramedullary plasmacytoma (EMP) sub-group, must have radiologically measurable EMP disease (soft tissue or bone related) that is amenable to biopsy and does not need to have measurable disease.

Exclusion Criteria:

  • Has non-secretory or oligosecretory multiple myeloma
  • Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
  • Has undergone prior organ or allogeneic hematopoetic stem cell transplantation
  • Has received previous therapy with pomalidomide and did not achieve at least a stable disease
  • Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), antiprogrammed death-ligand 1 (anti-PD-L1), antiprogrammed death-ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
  • Has received prior treatment with a monoclonal antibody within 5 half-lives of Study Day 1
  • Has received investigational agents within 28 days or 5 half-lives (whichever is longer) of Study Day 1
  • Has received live, attenuated vaccine within 30 days prior to Study Day 1
  • Had rash ≥ Grade 3 during prior thalidomide, lenalidomide, or pomalidomide therapy
  • Has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, POM, or dex
  • Has peripheral neuropathy ≥ Grade 2
  • Has a known additional malignancy that is progressing or requires active treatment (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy).
  • Is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C
  • Has a prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years (with the exception Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer [T1a or T1b] or prostate cancer that is curative)
  • Has clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma
  • Has clinically significant cardiac disease
  • Is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study
  • Is a current smoker
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616640


  Show 35 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Lars Sternas, MD, PhD Celgene Corporation
  More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02616640     History of Changes
Other Study ID Numbers: MEDI4736-MM-001
First Submitted: November 25, 2015
First Posted: November 30, 2015
Last Update Posted: September 28, 2017
Last Verified: September 2017

Keywords provided by Celgene:
Multiple Myeloma
Relapsed
Refractory
MEDI4736
Durvalumab
Pomalidomide (POM)
Dexamethasone (DEX)
PD-L1

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Pomalidomide
Thalidomide
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal