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NCT01562405 · ClinicalTrials.gov registry record · Phase 1

Sotatercept (ACE-011) With Lenalidomide or Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma

A Phase 1 study of Multiple Myeloma, sponsored by Massachusetts General Hospital.

Active
Registry status
Phase 1
Development phase
33
Enrollment target
4
Study locations

NCT01562405: Active Phase 1 study of Multiple Myeloma, sponsored by Massachusetts General Hospital.

NCT01562405 is a Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 33 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01562405, a Phase 1 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Massachusetts General Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
33 participants
Enrollment target
4
Study locations

Study Summary

It is possible that the combination of lenalidomide, dexamethasone and ACE 011 may reduce or prevent the growth of cancer cells along with improving anemia and bone lesions that sometimes occur in people with multiple myeloma. This current study is the first study combining ACE 011 with lenalidomide. In this research study, the investigators are looking for the highest dose of ACE 011 that can be given with lenalidomide and dexamethasone. The investigators will also begin to collect information about the effect of the combination of ACE 011, lenalidomide and dexamethasone on multiple myeloma.

Primary Outcome

Identify the maximum tolerated dose of ACE-011 given in combination with lenalidomide and dexamethasone in subjects with relapsed multiple myeloma

Conditions Studied

Interventions

  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Pomalidomide
  • DRUG ACE-011

Study Locations (4)

Massachusetts

  • Massachusetts General Hosptial - Boston
  • Brigham and Women's Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

Georgia

  • Emory University - Atlanta

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2012-05
Est. Completion 2027-12
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What the registry record for NCT01562405 still lists

NCT01562405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 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 Dexamethasone is the first listed.

NCT01562405 reports a single indexed study location in Massachusetts, Georgia.

Frequently Asked Questions

What is clinical trial NCT01562405 about?

NCT01562405 is a clinical study titled "Sotatercept (ACE-011) With Lenalidomide or Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma". It is possible that the combination of lenalidomide, dexamethasone and ACE 011 may reduce or prevent the growth of cancer cells along with improving anemia and bone lesions that sometimes occur in people with multiple myeloma. This current study is the first study combining ACE 011 with lenalidomid...

What is the current status of trial NCT01562405?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2012-05. Estimated completion is 2027-12.

What conditions does trial NCT01562405 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT01562405?

The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Pomalidomide (DRUG), ACE-011 (DRUG).

Who is sponsoring clinical trial NCT01562405?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01562405 being conducted?

This trial has 4 study locations across Georgia, Massachusetts. 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 NCT01562405's enrollment target sits among peer trials

33 320th of 438 higher than 116 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 NCT01562405, the US trial registry maintained by the National Library of Medicine. NCT01562405 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.