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Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02462525
Recruitment Status : Terminated (No Go decision for ABBV-838)
First Posted : June 4, 2015
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: ABBV-838 Drug: Pomalidomide Drug: Dexamethasone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
Actual Study Start Date : May 6, 2015
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: ABBV-838 dose escalation
Varying doses of ABBV-838
Drug: ABBV-838
Varying doses of ABBV-838

Experimental: ABBV-838 plus pomalidomide/dexamethasone
ABBV-838 to be evaluated with pomalidomide/dexamethasone.
Drug: ABBV-838
Varying doses of ABBV-838

Drug: Pomalidomide
Administered orally per the label.

Drug: Dexamethasone
Administered orally per the label.




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of ABBV-838 [ Time Frame: Cycle 1 Day 1 (C1D1) and C3D1 pre- and post-dose; C1D4, C1D8, C1D15, C2D1, C2D15, C3D4, C3D8, C3D15, C4D1, and all subsequent ABBV-838 pre-dose dosing cycles ]
    The maximum plasma concentration (Cmax: measured in ng/ml) is the highest concentration that a drug achieves in the blood after the first dose, but before administration of a second dose.

  2. Maximum tolerated dose of ABBV-838 [ Time Frame: Up to 2 years from first dose of study ]
    The highest dose level at which less than 2 of 6 subjects or less than 33% of (if cohort is expanded beyond 6) subjects experience a dose limiting toxicity.


Secondary Outcome Measures :
  1. Preliminary activity of ABBV-838 monotherapy [ Time Frame: At screening, Cycle 1 Day 15 (C1D15), C3D15, C4D1, and for subjects who have been on ABBV-838 for ≥ 6 cycles, radiologic tumor assessments may be performed every 3 cycles per Investigator discretion up to approximately 3 years ]
    Response evaluation will be based on International Myeloma Working Group (IMWG) Response Criteria.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group Performance Status of 0 to 2
  • Not eligible for stem cell/bone marrow transplant or have refused stem cell/bone marrow transplant or have relapsed after autologous or allogeneic stem cell/bone marrow transplant
  • Eligible for and agree to BM aspirate prior to treatment start
  • Measurable disease M component in serum (≥ 0.5 g/dL) and/or urine (≥ 0.2 g excreted in a 24 hour collection sample)
  • Must have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or those who are double refractory to a PI and an immunomodulatory agent and have demonstrated disease progression (DP) on or within 60 days of completion of the last therapy; participants previously treated with an alkylating agent, in addition to an IMiD or proteasome inhibitor, are allowed to enroll in the trial
  • Participants must have adequate liver, kidney, and bone morrow function
  • Participants with a history of chronic heart failure must have cardiac ECHO indicating left ventricular ejection fraction (LVEF) ≥ 45% within 21 days prior to first dose of study drug
  • Participants in the combination therapy arms must be eligible to receive pomalidomide/dexamethasone, bortezomib/dexamethasone or lenalidomide/dexamethasone or other approved agents per current prescribing information for MM.
  • Participants who will receive combination therapy with Pomalidomide/Dexamethasone must have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy

Exclusion Criteria:

  • Received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, any investigational therapy or herbal therapy within a period of 21 days prior to the first dose of ABBV-838, and have unresolved toxicities ≥ grade 2
  • Concurrent metastatic solid tumors
  • Non-Measurable M Protein (serum or urine) and measurable sFLC (< 100 mg/mL)
  • Major surgery within 21 days prior to the first dose of ABBV-838
  • Clinically significant uncontrolled condition(s) including but not limited to the following:

Grade ≥ 3 peripheral neuropathy or grade 2 peripheral neuropathy with pain Uncontrolled hypercalcemia Active uncontrolled infection Symptomatic congestive heart failure Unstable angina pectoris or cardiac arrhythmia Psychiatric illness/social situation that would limit compliance with the study

  • Major immunologic reaction to any IgG containing agent or auristatin based agent
  • Participants who are taking strong CYP3A4 inhibitors
  • Positive for HIV (Human Immunodeficiency Virus) or with active hepatitis B and/or C
  • Corneal pathology that would limit evaluation of loss in visual acuity associated with corneal deposits.
  • Prior exposure to pomalidomide for subjects enrolling in the pomalidomide/dexamethasone combination arm.

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): NCT02462525


Locations
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United States, Illinois
The University of Chicago Medical Center /ID# 139403
Chicago, Illinois, United States, 60637
United States, Michigan
University of Michigan Medical Center /ID# 139402
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University School of Medicine /ID# 135708
Saint Louis, Missouri, United States, 63110-1093
United States, New York
Mount Sinai Medical Center /ID# 133569
New York, New York, United States, 10029
United States, Tennessee
The Sarah Cannon Research Institute /ID# 135814
Nashville, Tennessee, United States, 37203
France
CHRU de Lille, Hopital Claude Huriez /ID# 133634
Lille Cedex, France, 59037
CHU de Nantes, Hotel Dieu - HME /ID# 133633
Nantes Cedex 1, France, 44093
CHU de la miletrie, Centre d'investigation clinique /ID# 147542
Poitiers, France, 86021
Germany
Universitaetsklinikum Koeln /ID# 141535
Cologne, Germany, 50937
Universitaetklinikum Dresden /ID# 141860
Dresden, Germany, 01307
Universitaetsklinikum Heidelberg /ID# 140046
Heidelberg, Germany, 69210
Universitaetsklinikum Schleswig-Holstein /ID# 141534
Kiel, Germany, 24105
Universitaetsklinikum Tuebingen /ID# 141074
Tuebingen, Germany, 72076
Universitaetsklinikum Wuerzburg /ID# 141533
Wuerzburg, Germany, 97080
Spain
Hospital Clinic de Barcelona /ID# 141643
Barcelona, Spain, 08036
Hospital Universitario de la Princesa /ID# 140881
Madrid, Spain, 28006
Hospital Universitario 12 de Octubre /ID# 140878
Madrid, Spain, 28041
Clinica Universitaria de Navarra /ID# 141411
Pamplona-Navarra, Spain, 31008
Hospital Clinico Universitario Salamanca /ID# 140880
Salamanca, Spain, 37007
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02462525     History of Changes
Other Study ID Numbers: M14-467
2014-002609-39 ( EudraCT Number )
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by AbbVie:
relapsed multiple myeloma
antibody drug conjugate
refractory multiple myeloma

Additional relevant MeSH terms:
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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
Dexamethasone acetate
Pomalidomide
Thalidomide
BB 1101
Antibodies
Immunoglobulins
Immunoconjugates
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones