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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01562405
Recruitment Status : Active, not recruiting
First Posted : March 23, 2012
Last Update Posted : August 14, 2019
Multiple Myeloma Research Consortium
Information provided by (Responsible Party):
Andrew Yee, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: ACE-011 Drug: Lenalidomide Drug: Dexamethasone Drug: Pomalidomide Phase 1

Detailed Description:

After the screening procedures confirm that you are eligible to participate in the research study:

Assignment to dose level of study treatment Since we are looking for the highest dose of the ACE 011 combined with lenalidomide that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma, not everyone who participates in this research study will receive the same dose of these drugs. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.

Study treatment Study treatment will be given in 28 day cycles.

  • ACE-011 will be given as an injection under the skin, Day 1 of each cycle (every 28 days). You will receive each injection at the clinic.
  • Lenalidomide will be taken by mouth: once daily days 1 21, followed by a 7 day rest period during which no lenalidomide will be taken.
  • Dexamethasone will be taken by mouth once per week (days 1, 8, 15 and 22) of each cycle.

You will be given drug diaries to record the doses of lenalidomide and dexamethasone taken. The study staff will tell you how to complete the diaries

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Multicenter, Open-label, Dose-escalation Study of Sotatercept (ACE-011) in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Study Start Date : May 2012
Actual Primary Completion Date : May 2018
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: ACE-011 (sotatercept)
ACE-011, Lenalidomide or pomalidomide, Dexamethasone
Drug: ACE-011
Injection every 28 days, dose escalation levels from 15-45 mg
Other Name: Sotatercept

Drug: Lenalidomide
15 to 25 mg days 1-21, given orally
Other Name: Revlimid

Drug: Dexamethasone
40 mg days 1,8,15,22; given orally
Other Name: Decadron

Drug: Pomalidomide
Pomalidomide 4 mg daily on days 1-21
Other Name: Pomalyst

Primary Outcome Measures :
  1. Maximum Tolerated Dose of ACE-011 [ Time Frame: 2 years ]
    Identify the maximum tolerated dose of ACE-011 given in combination with lenalidomide and dexamethasone in subjects with relapsed multiple myeloma

Secondary Outcome Measures :
  1. Efficacy of ACE-011 [ Time Frame: 2 years ]
    • Objective response according to the International Myeloma Working Group Uniform Response Criteria
    • Duration of response
    • Time to progression
    • Progression-free survival

  2. Safety of ACE-011 [ Time Frame: 2 years ]
    • Adverse events profile
    • Toxicity profile as per NCI CTCAE v4.0

  3. Pharmacodynamic measures [ Time Frame: 2 years ]
    -Activin levels

  4. Pharmacodynamic markers [ Time Frame: 2 years ]
    Markers of bone turnover

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Monoclonal plasma cells in the bone marrow > 10% and/or presence of a biopsy-proven plasmacytoma
  • Monoclonal protein present in the serum and/or urine
  • Patient must have received at least 1 line of prior systemic therapy for the treatment of multiple myeloma. A line of treatment is sequential treatment without interruption for response and subsequent progression
  • For participants treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, two weeks must have lapsed since last date of radiotherapy, which is recommended to be a limited field. Participants who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and two weeks have passed since the last date of therapy.
  • ECOG performance status of zero to two unless decline is due to bony disease
  • Not pregnant or breastfeeding

Exclusion Criteria:

  • Participants who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Participants may not have received treatment with another investigational drug or device within 28 days prior to Day 1, or if the half life of the previous product is known, within 5 times the half life prior to dosing, whichever may be longer
  • Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ACE 011, Lenalidomide or Dexamethasone
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  • History of major surgery within 30 days prior to trial initiation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01562405

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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hosptial
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Multiple Myeloma Research Consortium
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Principal Investigator: Andrew J. Yee, MD Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Andrew Yee, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT01562405    
Other Study ID Numbers: 11-318
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Andrew Yee, MD, Massachusetts General Hospital:
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors