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Vorinostat (MK0683, SAHA) + Revlimid + Dexamethasone in Multiple Myeloma
This study is currently recruiting participants.
Verified by Merck, April 2009
First Received: March 17, 2008   Last Updated: April 1, 2009   History of Changes
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00642954
  Purpose

This is a Phase I study of vorinostat in combination with lenalidomide and dexamethasone in the patients with relapsed or refractory multiple myeloma.

Patients will receive up to 8 cycles treatment with 28-day in each cycle. The safety and tolerability of the combination regimen will be evaluated in this study.


Condition Intervention Phase
Relapsed or Refractory Multiple Myeloma
Drug: vorinostat
Drug: Comparator: lenalidomide
Drug: Comparator: Dexamethasone
Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Suberoylanilide hydroxamic acid Lenalidomide CC 5013 Dexamethasone Sodium Phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 44
Study Start Date: February 2008
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental

Dose escalation study. Level 1: 300 mg q.d. vorinostat 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 levels 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.

Drug: 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.
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.
Drug: Comparator: Dexamethasone
Dose escalation study. 40 mg q.d. Dexamethasone p.o. will be given in each levels 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is a male or female at lease 18 years old
  • Patient has relapsed or refractory MM and has 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 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 baby during the course of the study.
  • Patient has HIV infection
  • Patient has Hepatitis B/C infection
  • Patient is currently receiving treatment for another type of cancer other than skin or cervix cancer that has not been in remission for 5 years or longer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642954

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Massachusetts
Call for Information Recruiting
Boston, Massachusetts, United States, 02115
United States, New Jersey
Call for Information Recruiting
Hackensack, New Jersey, United States, 07601
United States, Texas
Call for Information Recruiting
Houston, Texas, United States, 77030-0000
France
Laboratoires Merck Sharp & Dohme - Chibret Recruiting
Paris Cedex 8, France, 75114
Contact: Jean-Marie Goehrs     33-1-4754-89-90        
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
No publications provided

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2007_511, MK0683-074
Study First Received: March 17, 2008
Last Updated: April 1, 2009
ClinicalTrials.gov Identifier: NCT00642954     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Anticarcinogenic Agents
Dexamethasone
Anti-Inflammatory Agents
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Dexamethasone acetate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hematologic Diseases
Blood Coagulation Disorders
Vorinostat
Vascular Diseases
Lenalidomide
Glucocorticoids
Multiple Myeloma
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anticarcinogenic Agents
Anti-Inflammatory Agents
Dexamethasone
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Vorinostat
Gastrointestinal Agents
Vascular Diseases
Lenalidomide
Enzyme Inhibitors
Protective Agents

ClinicalTrials.gov processed this record on May 07, 2009