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.|
|ClinicalTrials.gov Identifier: NCT01562405|
Recruitment Status : Active, not recruiting
First Posted : March 23, 2012
Last Update Posted : March 20, 2019
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|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||August 2019|
Experimental: ACE-011 (sotatercept)
ACE-011, Lenalidomide or pomalidomide, Dexamethasone
Injection every 28 days, dose escalation levels from 15-45 mg
Other Name: Sotatercept
15 to 25 mg days 1-21, given orally
Other Name: Revlimid
40 mg days 1,8,15,22; given orally
Other Name: Decadron
Pomalidomide 4 mg daily on days 1-21
Other Name: Pomalyst
- 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
- 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
- Safety of ACE-011 [ Time Frame: 2 years ]
- Adverse events profile
- Toxicity profile as per NCI CTCAE v4.0
- Pharmacodynamic measures [ Time Frame: 2 years ]-Activin levels
- Pharmacodynamic markers [ Time Frame: 2 years ]Markers of bone turnover
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 ClinicalTrials.gov identifier (NCT number): NCT01562405
|United States, Georgia|
|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|
|Principal Investigator:||Andrew J. Yee, MD||Massachusetts General Hospital|