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NCT01054196 · ClinicalTrials.gov registry record · Phase 1

Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study

A Phase 1 study of Multiple Myeloma, sponsored by Weill Medical College of Cornell University.

Active
Registry status
Phase 1
Development phase
52
Enrollment target
1
Study location

NCT01054196: Active Phase 1 study of Multiple Myeloma, sponsored by Weill Medical College of Cornell University.

NCT01054196 is a Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 52 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01054196, a Phase 1 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Weill Medical College of Cornell University.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
52 participants
Enrollment target
1
Study location

Study Summary

A) Phase 1: To determine the maximal tolerated dose (MTD) of lenalidomide that can be safely added to high-dose melphalan prior to autologous stem cell transplantation (ASCT). B) Phase 2: To determine whether the addition of high-dose lenalidomide to ASCT followed by maintenance standard-dose lenalidomide improves the response rate and duration of response for relapsed multiple myeloma (RMM).

Primary Outcome

The primary endpoint for the phase 1 portion of this study is to determine the maximum tolerated dose of lenalidomide that can be added to melphalan.

Conditions Studied

Interventions

  • DRUG lenalidomide
  • DRUG melphalan

Study Locations (1)

New York

  • Weill Cornell Medical College - New York

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2010-08
Est. Completion 2026-12
Phase Phase 1

What the registry record for NCT01054196 still lists

NCT01054196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which lenalidomide is the first listed.

NCT01054196 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT01054196 about?

NCT01054196 is a clinical study titled "Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study". A) Phase 1: To determine the maximal tolerated dose (MTD) of lenalidomide that can be safely added to high-dose melphalan prior to autologous stem cell transplantation (ASCT). B) Phase 2: To determine whether the addition of high-dose lenalidomide to ASCT followed by maintenance standard-dose lenal...

What is the current status of trial NCT01054196?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2010-08. Estimated completion is 2026-12.

What conditions does trial NCT01054196 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT01054196?

The interventions under investigation include: lenalidomide (DRUG), melphalan (DRUG).

Who is sponsoring clinical trial NCT01054196?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01054196 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT01054196's enrollment target sits among peer trials

52 245th of 438 higher than 189 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

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Source: ClinicalTrials.gov NCT01054196, the US trial registry maintained by the National Library of Medicine. NCT01054196 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.