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: Completed Phase 2 study of Multiple Myeloma, sponsored by University of Michigan Rogel Cancer Center.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

The primary efficacy endpoint is complete response rate. The complete response rate was estimated by the observed proportion of complete responders at day 180. Complete response (CR) was defined as negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow and negative bone marrow flow cytometry.

Conditions Studied

Multiple Myeloma

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

FieldValue
Enrollment Target 32 participants
Start Date 2015-06
Est. Completion 2017-06
Phase Phase 2
University of Michigan Rogel Cancer Center

292 total trials

What the finished NCT02331368 record still lists

NCT02331368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower).

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 a single indexed study location in 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.

Where NCT02331368's enrollment target sits among peer trials

32 324th of 438 higher than 104 of 438 other Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02445781 · 32 participants · Early Phase 1

    Differing Levels of Hypoglycemia

  • NCT02792270 · 32 participants · NA

    Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

  • NCT03068910 · 32 participants · Early Phase 1

    Hyperandrogenemia and Altered Day-night LH Pulse Patterns

  • NCT03208868 · 32 participants · NA

    Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Related registry views

Source: ClinicalTrials.gov NCT02331368, the US trial registry maintained by the National Library of Medicine. NCT02331368 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.