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Early trial of lenalidomide after transplant for myeloma stopped early

NCT ID NCT01421927

Disease control Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 1 trial tested the safety of the drug lenalidomide as maintenance therapy after a reduced-intensity stem cell transplant for multiple myeloma. Only 13 people took part, and the study was terminated early. The goal was to see if lenalidomide could help prevent the cancer from coming back without causing too many side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lenalidomide
What this could lead to
If successful, this could point toward a way to lower the chance of cancer returning after a stem cell transplant for multiple myeloma.
What could go wrong
This was a very small, early-phase trial that was terminated early, so results are limited. Lenalidomide can cause serious side effects like low blood counts and graft-versus-host disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Start date

Aug 2011

Finished

Oct 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged 18 to 65 years * Multiple Myeloma in 2nd or 3rd complete or partial response\* * Disease never refractory to lenalidomide * Lenalidomide treatment ≤ 9 months * HLA related or unrelated donor (matched 10/10 or mismatched 9/10 HLA-C high resolution level or HLA-DQ high or low resolution level) * Insured under Social Security * Information and consent signed Exclusion Criteria: * Stable or progressive disease * Hypersensitivity to lenalidomide or excipients * Lenalidomide treatment \> 9 months * Absence of efficient contraception in women or men * Cardiac insufficiency (ejection fraction \< 50% by echocardiography) * Pulmonary disease characterized by DLCO \< 60% * Severe renal insufficiency (clearance of creatinin \< 30 ml/min) * Hepatic disease characterized by ASAT and/or ALAT and/or total bilirubin \> 2 times the upper normal value except in case of Gilbert's disease * Bacterial, Viral or Fungal uncontrolled infections * No contraceptive method for Female subjects of childbearing potential * No use of condoms for males subjects * Pregnant or breast feeding woman * History of previous cancer (other than myeloma) except if the patient is in complete remission for more than 5 years.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33600, France

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