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NCT01954784 · ClinicalTrials.gov registry record · Phase 1

Lenalidomide After Donor Stem Cell Transplant and Bortezomib in Treating Patients With High Risk Multiple Myeloma

A Phase 1 study, sponsored by Case Comprehensive Cancer Center.

Terminated
Registry status
Phase 1
Development phase
8
Enrollment target

NCT01954784: Clinical Trial Phase 1 study, sponsored by Case Comprehensive Cancer Center.

NCT01954784 is a Phase 1 study that was terminated before completion, run by Case Comprehensive Cancer Center. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01954784, a Phase 1 study, was terminated before completion, sponsored by Case Comprehensive Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of lenalidomide after donor stem cell transplant and bortezomib in treating patients with high-risk multiple myeloma. Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a bortezomib at the time of transplant may stop this from happening. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after donor stem cell transplant may be an effective treatment for multiple myeloma.

Interventions

  • DRUG fludarabine phosphate
  • DRUG cyclosporine
  • RADIATION total-body irradiation
  • DRUG mycophenolate mofetil
  • PROCEDURE nonmyeloablative allogeneic hematopoietic stem cell transplantation

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2013-10-07
Est. Completion 2017-01-30
Phase Phase 1
Case Comprehensive Cancer Center

407 total trials

Why NCT01954784 stopped before completion

NCT01954784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.

NCT01954784 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01954784 about?

NCT01954784 is a clinical study titled "Lenalidomide After Donor Stem Cell Transplant and Bortezomib in Treating Patients With High Risk Multiple Myeloma". This phase I trial studies the side effects and best dose of lenalidomide after donor stem cell transplant and bortezomib in treating patients with high-risk multiple myeloma. Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of can...

What is the current status of trial NCT01954784?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-10-07. Estimated completion is 2017-01-30.

What interventions are being tested in trial NCT01954784?

The interventions under investigation include: fludarabine phosphate (DRUG), cyclosporine (DRUG), total-body irradiation (RADIATION), mycophenolate mofetil (DRUG), nonmyeloablative allogeneic hematopoietic stem cell transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT01954784?

This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01954784's enrollment target sits among peer trials

8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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

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Source: ClinicalTrials.gov NCT01954784, the US trial registry maintained by the National Library of Medicine. NCT01954784 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.