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BCL-2 Inhibitor

AMG 176 for Multiple Myeloma

Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
(MM participants only) Satisfactory hematological function without transfusion or growth factor support
Adequate cardiac function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for people with cancer who have not responded to other treatments.

Who is the study for?
This trial is for adults in Japan with relapsed or refractory multiple myeloma after at least two treatments, or acute myeloid leukemia not responding to treatment (excluding acute promyelocytic leukemia). Participants must have good heart, kidney, and liver function, no recent severe heart issues or strokes, and a life expectancy over three months. Women of childbearing age need a negative pregnancy test.Check my eligibility
What is being tested?
The trial tests the safety and tolerability of AMG 176 on participants with specific blood cancers who have tried other treatments without success. It includes those with multiple myeloma or acute myeloid leukemia to see how they respond to this new potential therapy.See study design
What are the potential side effects?
While the exact side effects are not listed here, typical ones from cancer drugs like AMG 176 may include nausea, fatigue, risk of infection due to low blood cell counts, liver problems indicated by certain blood markers, and potential heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood counts are stable without needing transfusions or medications to help.
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My heart is functioning well.
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I am a woman who can have children and have a negative pregnancy test.
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My kidneys are working well.
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If I am under 20 and in Japan, both I and my legal guardian have given consent.
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My AML has come back or didn't respond to treatment, and I can't use approved drugs in Japan.
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I am willing to have a bone marrow biopsy and aspirate.
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I can take care of myself but might not be able to do heavy physical work.
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My liver is working well.
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My multiple myeloma has returned or didn't respond after 2 treatments.
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I have AML with over 5% bone marrow blasts and less than 25,000 white blood cells/ul.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AML Part 3a Incidence of clinically significant changes in ECGs
AML Part 3a Incidence of clinically significant changes in clinical laboratory tests
AML Part 3a Incidence of clinically significant changes in vital signs
+70 more
Secondary outcome measures
AML Part 3a, 3b and 3c Duration of response (DOR)
AML Part 3a, 3b and 3c Event free survival (EFS)
AML Part 3a, 3b and 3c Overall response (OR) according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017)
+23 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: AMG 176 - Part 5Experimental Treatment2 Interventions
Part 5 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion at the maximum tolerated combination dose from Part 4, either once a week (QW) followed by 6 days break, or once a day, for two-consecutive days (QD2), in combination with azacitidine.
Group II: AMG 176 - Part 4Experimental Treatment2 Interventions
Part 4 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, either once a week (QW) followed by 6 days break, or once a day, for two-consecutive days (QD2), in combination with azacitidine.
Group III: AMG 176 - Part 3dExperimental Treatment2 Interventions
Part 3d - Participants in the United States with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW), for 3 weeks, in combination with itraconazole.
Group IV: AMG 176 - Part 3cExperimental Treatment1 Intervention
Part 3c - Participants in Japan only with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.
Group V: AMG 176 - Part 3bExperimental Treatment1 Intervention
Part 3b - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.
Group VI: AMG 176 - Part 3aExperimental Treatment1 Intervention
Part 3a - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion once a day, for two-consecutive days (QD2) followed by a 5 day break.
Group VII: AMG 176 - Part 1bExperimental Treatment1 Intervention
Part 1b - Participants with multiple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.
Group VIII: AMG 176 - Part 1aExperimental Treatment1 Intervention
Part 1a - Participants with muliple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion for two-consecutive days (QD2) followed by a 5 days break.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Itraconazole
2017
Completed Phase 2
~780
AMG 176
2022
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,355 Previous Clinical Trials
1,383,929 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,604 Patients Enrolled for Multiple Myeloma
MDStudy DirectorAmgen
899 Previous Clinical Trials
921,606 Total Patients Enrolled
44 Trials studying Multiple Myeloma
11,203 Patients Enrolled for Multiple Myeloma

Media Library

AMG 176 (BCL-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02675452 — Phase 1
Multiple Myeloma Research Study Groups: AMG 176 - Part 3a, AMG 176 - Part 3c, AMG 176 - Part 3d, AMG 176 - Part 5, AMG 176 - Part 1a, AMG 176 - Part 1b, AMG 176 - Part 3b, AMG 176 - Part 4
Multiple Myeloma Clinical Trial 2023: AMG 176 Highlights & Side Effects. Trial Name: NCT02675452 — Phase 1
AMG 176 (BCL-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02675452 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total population size of individuals participating in this medical research?

"A total of 175 individuals meeting the prerequisites need to enroll in this experiment, with locations available at John Theurer Cancer Center and University of Colorado."

Answered by AI

What are the desired outcomes of this research endeavor?

"As reported by Amgen, the main objective of this trial that will be evaluated over a 6-month period is to measure the incidence of clinically significant changes in clinical laboratory tests for Acute Myeloid Leukemia (AML) Part 3b. Additionally, secondary outcomes such as Multiple myeloma (MM) Part 1b overall response according to international myeloma working group uniform response criteria and AML Parts 3d Incidence of Clinically Significant Changes in Vital Signs, as well as 4 Event Free Survival (EFS), will also be monitored."

Answered by AI

What have previous explorations revealed about AMG 176's efficacy?

"The initial research into AMG 176 was conducted in 2006 at the Chinese University of Hong Kong-Prince of Wales Hospital. Up to now, there have been 377 completed clinical studies dedicated to this drug and presently 187 trials are actively seeking participants with many being hosted out of Hackensack, New jersey."

Answered by AI

Does this research accommodate elders more than sixty-five years of age?

"This experiment has a wide age range, from 18 to 85 years of age. Those younger than 18 can look into 471 trials while those older than 65 have the choice of 2074 studies."

Answered by AI

Is it possible for me to join the ongoing clinical trial?

"This clinical trial will accept 175 participants aged 18 to 85 with multiple myeloma. In order to be eligible, individuals must meet the following requirements: have AML as defined by WHO persisting or recurring after one or more courses of treatment; life expectancy greater than 3 months; adequate hepatic function and ECOG performance status of no higher than 2 (except for those in Japan who are not eligible for approved anticancer drug therapy)."

Answered by AI

Are there any opportunities for participants to enter this research study?

"According to clinicaltrials.gov, this study is still enrolling participants as of November 16th 2022. Initially posted on June 13th 2016, the trial has been regularly updated since then."

Answered by AI

Are there various locales running this experiment across the state?

"This clinical trial has 11 locations available for patient recruitment, including John Theurer Cancer Center at Hackensack University Medical Center in New jersey, the University of Colorado in Aurora and University of Texas MD Anderson Cancer Centre located in Houston. Other 8 sites are also accepting applications from potential participants."

Answered by AI

Is AMG 176 recognized by the Food and Drug Administration as safe for use?

"With only a small amount of data supporting its safety and efficacy, AMG 176 was assigned a score of 1 on the risk scale."

Answered by AI

What medical conditions is AMG 176 employed to treat?

"AMG 176 is a popular treatment for chromomycosis and as an adjunct to complete blood count, induction chemotherapy, and vulvovaginal candidiasis."

Answered by AI
~3 spots leftby Jun 2024