Multiple MyelomaPhase 1NCT01583283

Study of ACY-1215 in Combination With Lenalidomide, and Dexamethasone in Multiple Myeloma

A Phase 1 study testing ACY-1215, lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: ACY-1215, lenalidomide and Dexamethasone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 5 sitesUnited States
Study dates: 12 Jul 2012to 24 Mar 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Relapsed or Relapsed/Refractory MM with progressive disease (PD) according to IMWG.
Received at least 1 prior line of therapy for MM (Phase 1)
Secretory MM for which the patient previously received 1-3 prior lines of therapy (Phase 2).
Able to provide written consent
Not a candidate for autologous stem cell transplant (ASCT) or declined option.
≥18 years of age

Show all 16Show fewer

Karnofsky Performance Status score ≥ 70
Adequate bone marrow reserve as evidenced by ANC > 1.0x10^9/L;Platelet > 50x10^9/L
Creatinine Clearance of ≥ 50 mL/min
Adequate hepatic function as evidenced by serum bilirubin values < 2.0 mg/dL; ALT and/or AST < 3xULN.
Corrected serum calcium ≤ ULN
Recovered from the effects of any prior systemic therapy or radiotherapy for Multiple Myeloma
Able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulated, with an INR of 2 or 3.
Agreement to participate in RevAssist® Program
Female of childbearing potential must have a negative serum or urinary pregnancy test with a sensitivity of at least 50 mIU/mL 10-14 days prior to and again within 24 hours of prescribing lenalidomide for Cycle 1 and must either commit to continued abstinence or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days prior to taking lenalidomide. Also agree to ongoing pregnancy testing.
If male, including those who have had a vasectomy, must agree to use a latex condom during any sexual contact with a female of childbearing potential.

Who cannot join

Received any of the following antitumor therapies
Radiotherapy or systemic therapy within 2 weeks of Cycle 1 Day 1 (C1D1)
Investigational or biologic therapies within 3 weeks of C1D1
Prior peripheral ASCT within 12 weeks of C1D1
Prior allogeneic stem cell transplant
Prior treatment with a histone deacetylase (HDAC) inhibitor

Show all 17Show fewer

Presence of an active systemic infection requiring treatment.
History of other malignancies unless a.) the patient has undergone definitive treatment more than 5 years prior and is without evidence of recurrent malignant disease or b.) had basal or squamous cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with current prostat specific antigen < 0.1 ng/mL; ductal carcinoma in situ; or cervical intraepithelial neoplasia.
Known or suspected human immunodeficiency virus (HIV), hepatitis B surface antigen-positive status or known or suspected active hepatitis C infection.
If female, is lactating.
History of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including but not limited to congestive heart failure (NYHA Class 3 or 4), unstable angina; cardiac arrhythmia, recent (within past 6 months) myocardial infarction or stroke; uncontrolled hypertension; diabetes mellitus with >2 episodes of ketoacidosis in the preceding 12 months, COPD requiring >2 hospitalizations in preceding 12 months
QTcF > 480 msec, family or personal history of long QTc syndrome or ventricular bigeminy; previous history of drug-induced QTc prolongation or the need for medications known or suspected of producing prolonged QTc intervals on ECG
Current enrollment in another clinical trial involving treatment and/or is receiving an investigational agent for any reason
Documented plasma cell leukemia or known amyloidosis. (Plasma cell leukemia is defined as the presence of >20% plasma cells in the peripheral blood and an absolute plasma cell count of ≥2000 muL
Known hypersensitivity to thalidomide or lenalidomide.
History of erythema nodosum characterized by desquamating rash while taking thalidomide or similar drugs.
Non-secretory or oligo-secretory Multiple Myeloma (Phase II only; such disease is permissible in Phase I).

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 2114
University of North Carolina
Chapel Hill, North Carolina, 27599
Sarah Cannon Research Institute Drug Development Unit
Nashville, Tennessee, 37203
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase 1/2, Open-Label, Multicenter Study of ACY-1215 (Ricolinostat) in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma

The purpose of this study is to determine the best dose of ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Once determined, the purpose of this study will be to determine the efficacy of ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma who have had 1-3 prior therapies and who are not lenalidomide-refractory.

Read the detailed description

This is phase 1, single-arm, multicenter, open-label study in patients with relapsed or relapsed/refractory MM. The study employs a sequential group dose-escalation design to determine the DLT and MTD of ACY-1215 in combination with lenalidomide and dexamethasone, all administered orally (PO). The safety, tolerability, single- and multiple-dose PK, pharmacodynamics, and anti-tumor activity of ACY 1215 in combination with lenalidomide and dexamethasone also will be evaluated.

Each cohort will enroll 3 patients. Study drug doses will be escalated sequentially after the Safety Review Committee (SRC) reviews safety data collected in C1 (28 days) from patients enrolled at the current dose level as well as emerging data from ongoing studies of ACY-1215. If there are no DLTs (as defined in Section 5.2.6) during C1 or concerns based on data from other ongoing studies, the study will proceed with dose escalation to the next cohort following safety data review by the SRC. If 1 of 3 patients has a DLT, then up to 3 additional patients will be enrolled in that cohort; if none of the additional 3 patients experience a DLT during C1, escalation may then continue to the next cohort following SRC review. If 2 or more patients have DLTs during C1, the DLT dose level will have been reached.

The MTD is defined as the dose level immediately below the DLT dose level. A total of up to 6 additional patients may be enrolled at the MTD or other appropriate dose level to obtain additional AE, PK, pharmacodynamic, and anti-tumor activity data on ACY 1215 in combination with lenalidomide and dexamethasone.

Conditions: Multiple Myeloma
Being tested: ACY-1215, lenalidomide, Dexamethasone
Keywords: Multiple Myeloma, Relapsed, Refractory, Histone deacetylase inhibitors, Lenalidomide, Revlimid, Dexamethasone
Medical subject headings: Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACY-1215Drug
Also called Histone deacetylase inhibitor
Dose escalation up to 480 mg administered orally on Days 1-5, 8-12 and 15-19 of a 28 day dosing schedule.
lenalidomideDrug
Also called Revlimid
Dosed on Days 1-21 of a 28 day cycle.
DexamethasoneDrug
Also called steroid
Dosed on Days 1, 8, 15 and 22 of a 28 day treatment cycle.

Study groups in NCT01583283
Study group	Role	What they receive
ACY-1215, Lenalidomide and Dexamethasone	Experimental	Open label dosing cohorts will evaluate oral ACY-1215 (doses ranging from 40 - 480 mg days 1-5, 8-12, 15-19) in combination with oral Lenalidomide (doses ranging from 15 - 25 mg days 1-21) and oral Dexamethasone (40 mg once weekly). Receives: Drug: ACY-1215; Drug: lenalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine DLT of ACY-1215 administered in combination with lenalidomide and dexamethasone in patient with relapsed/refractory MM
Number of participants with Dose Limiting Toxicity (DLT)
Measured: up to 7 years
To determine MTD of ACY-1215 administered in combination with lenalidomide and dexamethasone in patient with relapsed/refractory MM
Maximum Tolerated Dose is defined as the dose level immediately below the DLT dose level.
Measured: up to 7 years
Objective Response Rate of ACY-1215
The objective response rate is the proportion of subjects achieving an investigator conformed partial response (PR) or better, to treatment according to IMWG (International Myeloma Working Group).
Measured: up to 7 years

Secondary outcomes (10)

Duration of Response
The duration of response is defined as the time (in weeks) from the date of the first documentation of objective response to the first documentation of objective tumor progression or death on study due to any cause, whichever comes first.
Measured: Up to approximately 7 years
Adverse Events (AEs)
Number of participants with adverse event
Measured: From enrollment until at least 28 days after completion of study treatment
Disease Control Rate
Disease control rate is defined as the proportion of subjects with a response (Unconfirmed or Confirmed) of SD or better, more specifically sCR, CR, VGPR, PR, MR, or SD respectively.
Measured: Up to approximately 7 years
Progression-free Survival
PFS is defined as the time (in weeks) from the date of first dose to the date of first documentation of disease progression or death on study due to any cause, whichever comes first.
Measured: Up to approximately 7 years
Evaluate the pharmacodynamics of ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory MM
Exposure-response of ACY-1215 in combination with lenalidomide and dexamethasone, including biomarkers relating to intracellular protein acetylation, levels of proteins, messenger ribonucleic acid (mRNA) and microRNA expression profiles will be analyzed for potential relationships.
Measured: up to 28 days
Pharmacokinetic- Cmax
Maximum serum concentration
Measured: up to 28 days
Pharmacokinetic- Cmin
Minimum observed concentration
Measured: up to 28 days
Pharmacokinetic- Tmax
Time to maximum serum concentration
Measured: up to 28 days
Pharmacokinetic- AUC
Area under the plasma concentration time curve
Measured: up to 28 days
Pharmacokinetic- t1/2
Serum half-life
Measured: up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 201224 Mar 2021

First posted24 Apr 2012 (estimated)
Study start12 Jul 2012
Primary completion15 Mar 2021
Study completion24 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by CelgeneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01583283
Sponsor's protocol ID: ACE-MM-101
Status last verified: Feb 2022
First submitted: 11 Apr 2012
Last updated: 23 Feb 2022
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Clinical Study Report

Publications

Tamang D, et al. Tubulin Hyper-Acetylation In Blood Lymphocytes: Pharmacodynamic (PD) Biomarker For The Selective Histone Deacetylase (HDAC) 6 Inhibitor ACY-1215 In Multiple Myeloma (MM) Patients. Presented at American Society of Hematology 2013, December 7-10, 2013, New Orleans, LA. Abstract No. 3219.
Yee AJ, Bensinger WI, Supko JG, Voorhees PM, Berdeja JG, Richardson PG, Libby EN, Wallace EE, Birrer NE, Burke JN, Tamang DL, Yang M, Jones SS, Wheeler CA, Markelewicz RJ, Raje NS. Ricolinostat plus lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma: a multicentre phase 1b trial. Lancet Oncol. 2016 Nov;17(11):1569-1578. doi: 10.1016/S1470-2045(16)30375-8. Epub 2016 Sep 17.
PubMed 27646843
Yee, Andrew & Bensinger, William & Voorhees, Peter & Berdeja, Jesus & Richardson, Paul & Supko, Jeffrey & Tamang, David & Jones, Simon & Wheeler, Catherine & Markelewicz, Robert & Raje, Noopur. (2015). Ricolinostat (ACY-1215), the First Selective HDAC6 Inhibitor, in Combonation with Lenalidomide and Dexamethasone in Patients with Relapsed and Relapsed-and-Refractory Multiple Myeloma: Phase 1b Results (ACE-MM-101 Study). Blood 2015; 126(23): 3055-3055.doi: 10.1182/blood.v126.23.3055.3055.
Yee, Andrew & Voorhees, Peter & Bensinger, William & Berdeja, Jesus & Supko, Jeffrey & Richardson, Paul & Tamang, David & Jones, Simon & Patrick, Gretchen & Wheeler, Catherine & Raje, Noopur. (2014). Ricolinostat (ACY-1215), a Selective HDAC6 Inhibitor, in Combination with Lenalidomide and Dexamethasone: Results of a Phase 1b Trial in Relapsed and Relapsed Refractory Multiple Myeloma. Blood 2014; 124 (21): 4772-4772. doi:10.1182/blood.v124.21.4772.4772.
RICOLINOSTAT (ACY-1215), THE FIRST SELECTIVE HISTONE DEACETYLASE 6 INHIBITOR, IS ACTIVE AND WELL TOLDERATED IN COMBINATION WITH LENALIDOMIDE OR BORTEZOMIB IN PATIENTS WITH REFRACTORY MYELOMA Raje N. EHA ePoster Jun 13, 2014; 53804 P358 https://library.ehaweb.org/eha/2014/19th/53804/noopur.raje.ricolinostat.28acy-121529

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Open-Label, Multicenter Study of ACY-1215 (Ricolinostat) in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT01583283
Acronym / sponsor ID: ACE-MM-101
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma, Relapsed, Refractory, Histone deacetylase inhibitors, Lenalidomide, Revlimid, Dexamethasone
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: CelgeneIndustry (pharma, biotech, devices)
Study start: 12 Jul 2012 (actual)
Primary completion: 15 Mar 2021 (actual)
Study completion: 24 Mar 2021 (actual)
First posted: 24 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ACY-1215, Lenalidomide and Dexamethasone	Experimental	Drug: ACY-1215, Drug: lenalidomide, Drug: DexamethasoneOpen label dosing cohorts will evaluate oral ACY-1215 (doses ranging from 40 - 480 mg days 1-5, 8-12, 15-19) in combination with oral Lenalidomide (doses ranging from 15 - 25 mg days 1-21) and oral Dexamethasone (40 mg once weekly).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Relapsed or Relapsed/Refractory MM with progressive disease (PD) according to IMWG.
Received at least 1 prior line of therapy for MM (Phase 1)
Secretory MM for which the patient previously received 1-3 prior lines of therapy (Phase 2).
Able to provide written consent
Not a candidate for autologous stem cell transplant (ASCT) or declined option.

Key exclusion criteria (17 listed)

Received any of the following antitumor therapies
Presence of an active systemic infection requiring treatment.
History of other malignancies unless a.) the patient has undergone definitive treatment more than 5 years prior and is without evidence of recurrent malignant disease or b.) had basal or squamous cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with current prostat specific antigen < 0.1 ng/mL; ductal carcinoma in situ; or cervical intraepithelial neoplasia.
Known or suspected human immunodeficiency virus (HIV), hepatitis B surface antigen-positive status or known or suspected active hepatitis C infection.
If female, is lactating.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACY-1215Also: Histone deacetylase inhibitorDose escalation up to 480 mg administered orally on Days 1-5, 8-12 and 15-19 of a 28 day dosing schedule.	Drug	ACY-1215, Lenalidomide and Dexamethasone
lenalidomideAlso: RevlimidDosed on Days 1-21 of a 28 day cycle.	Drug	ACY-1215, Lenalidomide and Dexamethasone
DexamethasoneAlso: steroidDosed on Days 1, 8, 15 and 22 of a 28 day treatment cycle.	Drug	ACY-1215, Lenalidomide and Dexamethasone

Primary outcome

To determine DLT of ACY-1215 administered in combination with lenalidomide and dexamethasone in patient with relapsed/refractory MM
Time frame: up to 7 years
Number of participants with Dose Limiting Toxicity (DLT)
To determine MTD of ACY-1215 administered in combination with lenalidomide and dexamethasone in patient with relapsed/refractory MM
Time frame: up to 7 years
Maximum Tolerated Dose is defined as the dose level immediately below the DLT dose level.
Objective Response Rate of ACY-1215
Time frame: up to 7 years
The objective response rate is the proportion of subjects achieving an investigator conformed partial response (PR) or better, to treatment according to IMWG (International Myeloma Working Group).

10 secondary outcomes

Duration of Response
Time frame: Up to approximately 7 years
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
Disease Control Rate
Time frame: Up to approximately 7 years
Progression-free Survival
Time frame: Up to approximately 7 years
Evaluate the pharmacodynamics of ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory MM
Time frame: up to 28 days
Pharmacokinetic- Cmax
Time frame: up to 28 days
Pharmacokinetic- Cmin
Time frame: up to 28 days
Pharmacokinetic- Tmax
Time frame: up to 28 days
Pharmacokinetic- AUC
Time frame: up to 28 days
Pharmacokinetic- t1/2
Time frame: up to 28 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
BackgroundTamang D, et al. Tubulin Hyper-Acetylation In Blood Lymphocytes: Pharmacodynamic (PD) Biomarker For The Selective Histone Deacetylase (HDAC) 6 Inhibitor ACY-1215 In Multiple Myeloma (MM) Patients. Presented at American Society of Hematology 2013, December 7-10, 2013, New Orleans, LA. Abstract No. 3219.
Results publication: PubMed 27646843Yee AJ, Bensinger WI, Supko JG, Voorhees PM, Berdeja JG, Richardson PG, Libby EN, Wallace EE, Birrer NE, Burke JN, Tamang DL, Yang M, Jones SS, Wheeler CA, Markelewicz RJ, Raje NS. Ricolinostat plus lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma: a multicentre phase 1b trial. Lancet Oncol. 2016 Nov;17(11):1569-1578. doi: 10.1016/S1470-2045(16)30375-8. Epub 2016 Sep 17.
Results publicationYee, Andrew & Bensinger, William & Voorhees, Peter & Berdeja, Jesus & Richardson, Paul & Supko, Jeffrey & Tamang, David & Jones, Simon & Wheeler, Catherine & Markelewicz, Robert & Raje, Noopur. (2015). Ricolinostat (ACY-1215), the First Selective HDAC6 Inhibitor, in Combonation with Lenalidomide and Dexamethasone in Patients with Relapsed and Relapsed-and-Refractory Multiple Myeloma: Phase 1b Results (ACE-MM-101 Study). Blood 2015; 126(23): 3055-3055.doi: 10.1182/blood.v126.23.3055.3055.
Results publicationYee, Andrew & Voorhees, Peter & Bensinger, William & Berdeja, Jesus & Supko, Jeffrey & Richardson, Paul & Tamang, David & Jones, Simon & Patrick, Gretchen & Wheeler, Catherine & Raje, Noopur. (2014). Ricolinostat (ACY-1215), a Selective HDAC6 Inhibitor, in Combination with Lenalidomide and Dexamethasone: Results of a Phase 1b Trial in Relapsed and Relapsed Refractory Multiple Myeloma. Blood 2014; 124 (21): 4772-4772. doi:10.1182/blood.v124.21.4772.4772.
Results publicationRICOLINOSTAT (ACY-1215), THE FIRST SELECTIVE HISTONE DEACETYLASE 6 INHIBITOR, IS ACTIVE AND WELL TOLDERATED IN COMBINATION WITH LENALIDOMIDE OR BORTEZOMIB IN PATIENTS WITH REFRACTORY MYELOMA Raje N. EHA ePoster Jun 13, 2014; 53804 P358 https://library.ehaweb.org/eha/2014/19th/53804/noopur.raje.ricolinostat.28acy-121529
Individual participant dataSharing planned: Yes. Clinical Study Report

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACY-1215, lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine DLT of ACY-1215 administered in combination with lenalidomide and dexamethasone in patient with relapsed/refractory MM (time frame: up to 7 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01583283, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.