Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074 AM4)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00642954

First received: March 17, 2008

Last updated: February 20, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 17, 2008
Last Updated Date	February 20, 2013
Start Date ^ICMJE	February 2008
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 19, 2012)	Maximum Tolerated Dose (MTD) for the combination regimen [ Time Frame: From Cycle 1 Day 1 to approximately 8 months (8 cycles) ] [ Designated as safety issue: No ] Recommended Phase 2 Dose (RP2D) [ Time Frame: From Cycle 1 Day 1 to approximately 8 months (8 cycles) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 21, 2008)	Maximum Tolerated Dose (MTD) for the combination regimen [ Time Frame: Once MTD is found, you may get more treament in the extension study for approx 8 months until a bad side effects happens, your disease gets worse, or you withdrawal. If your disease does not get worse after 8 cycles, you may continue to treatment ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00642954 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 19, 2012)	Safety: Drug-Related Adverse Events (AEs) [ Time Frame: Every 2 months until: disease progression, start of new therapy, death or 2 years past last dose; whichever occurs first ] [ Designated as safety issue: Yes ] Tolerability: Dose-Limiting Toxicities [ Time Frame: Every 2 months until: disease progression, start of new therapy, death or 2 years past last dose; whichever occurs first ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 21, 2008)	Safety and tolerability; establish RP2D [ Time Frame: Will be followed every 2 months for long term safety, overall survival (OS), progression free survival (PS) until: disease progression, start of new therapy, death or 2 years past last dose; whichever occurs first ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074 AM4)
Official Title ^ICMJE	A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Brief Summary	The purpose of this Phase I study of vorinostat in combination with lenalidomide and dexamethasone in the patients with relapsed or refractory multiple myeloma is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The safety and tolerability of the combination regimen will also be evaluated in this study.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Relapsed or Refractory Multiple Myeloma
Intervention ^ICMJE	Drug: Comparator: vorinostat Dose escalation study. Level 1: 300 mg q.d. vorinostat p.o. for 14 days. Level 2,3, 4 & 5: 400 mg q.d. vorinostat p.o. for 14 days. Each treatment cycle will be 28 days with a maximum of 8 treatment cycles. Patients who do not have disease progression and who continue to meet the eligibility criteria after the 8 cycles will be offered continued treatment at the same dose level and schedule. Other Name: Zolinza Drug: Comparator: lenalidomide Dose escalation study. Level 1 & 2: 10 mg q.d. lenalidomide p.o. for 21 days. Level 3: 15 mg q.d. lenalidomide p.o. for 21 days. Level 4: 20 mg q.d. lenalidomide p.o. for 21 days. Level 5: 25 mg q.d. lenalidomide p.o. for 21 days. Each treatment cycle will be 28 days with a maximum of 8 treatment cycles. Other Name: Revlimid Drug: Comparator: dexamethasone Dose escalation study. 40 mg q.d. Dexamethasone p.o. will be given in each level on days 1, 8, 15, and 22 of each treatment cycle. Each treatment cycle will be 28 days with a maximum of 8 treatment cycles. Other Name: Decadron
Study Arm (s)	Experimental: Phase I Dose escalation study. Level 1: 300 mg daily (q.d.) vorinostat orally (p.o.) for 14 days in combination with 10 mg q.d. lenalidomide p.o. for 21 days. Level 2: 400 mg q.d. vorinostat p.o. for 14 days in combination with 10 mg q.d. lenalidomide p.o. for 21 days. Level 3: 400 mg q.d. vorinostat p.o. for 14 days in combination with 15 mg q.d. lenalidomide p.o. for 21 days. Level 4: 400 mg q.d. vorinostat p.o. for 14 days in combination with 20 mg q.d. lenalidomide p.o. for 21 days. Level 5: 400 mg q.d. vorinostat p.o. for 14 days in combination with 25 mg q.d. lenalidomide p.o. for 21 days. 40 mg q.d. Dexamethasone p.o. will be given in each level on days 1, 8, 15, and 22 of each treatment cycle. Each treatment cycle will be 28 days with a maximum of 8 treatment cycles. Patients who do not have disease progression and who continue to meet the eligibility criteria after the 8 cycles will be offered continued treatment at the same dose level and schedule. Interventions: Drug: Comparator: vorinostat Drug: Comparator: lenalidomide Drug: Comparator: dexamethasone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	28
Estimated Completion Date	May 2013
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient is a male or female at least 18 years old Patient has relapsed or refractory MM and has had at least one prior therapy Female patients of childbearing potential must have 2 negative serum pregnancy tests prior to receiving the first dose of study drugs Female patients who can become pregnant must agree to use 2 separate forms of effective birth control at the same time, 4 weeks before, while taking, and for 4 weeks after stopping lenalidomide. Post menopausal patients should be free from menses for > 2 years, or are surgically sterilized Male patient agrees to use an adequate method of contraception for the duration of the study, even if the patient has undergone a successful vasectomy Male patients must agree to use a latex condom during sexual contact with a pregnant female or a female who can become pregnant. This is required for the duration of the study, and for 4 weeks after stopping therapy Patient has at least 3 weeks washout prior to treatment Patient is able to swallow capsules and is able to take or tolerate oral medications on a continuous basis Exclusion Criteria: Patient has prior treatment with an histone deacetylase (HDAC) inhibitor Patient has prior allogenetic bone marrow transplant Patient has received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug Patient uses illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse Patient is pregnant or breast feeding or expecting to have a baby during the course of the study Patient has human immunodeficiency virus (HIV) infection Patient has Hepatitis B/C infection Patient is currently receiving treatment for another type of cancer other than skin or cervical cancer that has not been in remission for 5 years or longer
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00642954
Other Study ID Numbers ^ICMJE	0683-074, 2007_511
Has Data Monitoring Committee	Not Provided
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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