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NCT01750762 · ClinicalTrials.gov registry record · Phase 1

Lenalidomide After Allo Transplant

A Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.

Terminated
Registry status
Phase 1
Development phase
1
Enrollment target

NCT01750762: Clinical Trial Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.

NCT01750762 is a Phase 1 study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01750762, a Phase 1 study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.

TERMINATED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

This research is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved lenalidomide for your type of cancer. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, this study will determine the effect of lenalidomide on the growth of cancer cells. Lenalidomide is approved by the FDA for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental. There are some participants with multiple myeloma or lymphoma who have had very long remissions after a bone marrow/stem cell transplantation from another person. This is believed to be the effect of the donor's immune system reaction against the recipient's multiple myeloma cells. It is hoped that due to lenalidomide altering the immune system, it might be able to potentiate that reaction. This study is being done to determine if the use of lenalidomide is safe in transplant participants and if it can facilitate an immune reaction resulting in regression of the myeloma or lymphoma. During this study you will be evaluated for side effects from the treatment with lenalidomide (including graft versus host disease) and for response of the myeloma to the treatment. There will be two groups of participants in the study. The first group will be treated at a relatively low dose of lenalidomide. If this is found to be safe then the second

Primary Outcome

To determine the tolerability (with special attention to acute or chronic GVHD) and maximum tolerated dose (out of either 10 or 15 mg daily) of lenalidomide in patients with multiple myeloma or lymphoma who do not achieve a CR or relapse after an allogeneic SCT.

Interventions

  • DRUG Lenalidomide

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2012-12
Est. Completion 2014-03
Phase Phase 1

Why NCT01750762 stopped before completion

NCT01750762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.

NCT01750762 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01750762 about?

NCT01750762 is a clinical study titled "Lenalidomide After Allo Transplant". This research is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that researc...

What is the current status of trial NCT01750762?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2012-12. Estimated completion is 2014-03.

What interventions are being tested in trial NCT01750762?

The interventions under investigation include: Lenalidomide (DRUG).

Who is sponsoring clinical trial NCT01750762?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01750762's enrollment target sits among peer trials

1 2001st of 2000 the lowest 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 NCT01750762, the US trial registry maintained by the National Library of Medicine. NCT01750762 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.