Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02331368 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Multi-center Study of Anti-PD-1 During Lymphopenic State After HDT/ASCT for Multiple Myeloma
A Phase 2 study of Multiple Myeloma, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT02331368 is a Phase 2 study of Multiple Myeloma that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 32 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT02331368, a Phase 2 study of Multiple Myeloma, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
Multiple myeloma (MM) is a common incurable blood cancer causing debilitating symptoms-bone pain, kidney failure, low blood counts and infection. Chemotherapy outcomes are disappointing due to short-term response and long-term toxicities. 1. Studies showed these patients have weak immune against MM due to the immune checkpoint mediated by the PD1/PD-L1 interaction between immune cells and MM. Anti-PD-1 antibody (anti-PD1) disrupts this interaction, thus unleashing immune cell function and leading to killing of MM cells. 2. Studies further showed enhancement of this "unleash" after autologous transplant and better MM control by anti-PD1 when used after transplant. 3. Anti-PD1 has been extensively studied in patients with other cancers. It is very safe and effective and has been FDA-approved. Complications are of mild degree and easy to manage successfully in out-patient setting. Severe complications are rare. Thus, investigators proposed an efficacy study of anti-PD1 treatment after transplant to improve MM treatment outcomes. This was a collaborative study with Medical College of Wisconsin (headquarter of Center for International blood and Marrow Transplant Research). Investigators hypothesized that anti-PD1 treatment would increase the MM response and the MM control duration when added to the standard MM treatment after transplant. Anti-PD1 was given at the dose and interval, which had been studied previously (200 mg intravenous injection every 3 weeks) between 2 weeks until 6 months after transplant. Subjects were monitored closely during and after anti-PD1 therapy until at least 1 year post transplant. Late complications were followed for 3 years.
Conditions Studied
Interventions
- DRUG Melphalan
- DRUG Lenalidomide
- PROCEDURE Autologous Stem Cell Transplant
- DRUG MK-3475
Study Locations (2)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-06 |
| Est. Completion | 2017-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02331368
The ClinicalTrials.gov registry entry for NCT02331368 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Melphalan is the first listed.
NCT02331368 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Michigan, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT02331368 about?
NCT02331368 is a clinical study titled "Phase 2 Multi-center Study of Anti-PD-1 During Lymphopenic State After HDT/ASCT for Multiple Myeloma". Multiple myeloma (MM) is a common incurable blood cancer causing debilitating symptoms-bone pain, kidney failure, low blood counts and infection. Chemotherapy outcomes are disappointing due to short-term response and long-term toxicities. 1. Studies showed these patients have weak immune against MM...
What is the current status of trial NCT02331368?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2015-06. Estimated completion is 2017-06.
What conditions does trial NCT02331368 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT02331368?
The interventions under investigation include: Melphalan (DRUG), Lenalidomide (DRUG), Autologous Stem Cell Transplant (PROCEDURE), MK-3475 (DRUG).
Who is sponsoring clinical trial NCT02331368?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02331368 being conducted?
This trial has 2 study locations across Michigan, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant
RECRUITING · Phase 2
-
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
RECRUITING · Phase 2
-
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
RECRUITING · Phase 2
-
CAR T-cell Therapy in Patients With Renal Dysfunction
RECRUITING · Phase 2
-
IMMUNOPLANT for Newly Diagnosed Multiple Myeloma
RECRUITING · Phase 2
-
Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.