Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma

NCT00729118 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-08001NCI-2011-03140
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving vorinostat together with lenalidomide may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide after autologous stem cell transplant in treating patients with multiple myeloma.

Conditions

Multiple Myeloma; Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Safety of patients receiving SAHA and lenalidomide following autologous PBSCT

  Patients will be assessed for Adverse events using the NCI CTCAE version 4.0 criteria

  up to 3 years

Secondary Outcomes (7)

• Duration of response

  up to 3 years

• Time to progression (TTP)

  up to 3 years

• Progression-free survival (PFS)

  up to 3 years

• Time to response

  up to 3 years

• Duration of overall response

  up to 3 years

Study Arms (1)

Lenalidomide + Vorinostat

EXPERIMENTAL

Maintenance post autologous transplant

Drug: lenalidomide; Drug: vorinostat

Interventions

lenalidomide DRUG

combined with Vorinostat (SAHA) days 1-21 of a 28-day cycle until progression or clinically significant toxicity.

Also known as: Revlimid, CC-5013

Lenalidomide + Vorinostat

vorinostat DRUG

Vorinostat (SAHA) will be administered orally beginning at dose level 1 starting day +90 ±6 days after HSCT for days 1 and 15-21 of a 28-day cycle combined with lenalidomide days 1-21 of a 28-day cycle until progression or clinically significant toxicity.

Also known as: SAHA, Suberoylanilide hydroxamic acid

Lenalidomide + Vorinostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Has undergone melphalan-conditioned autologous peripheral blood stem cell transplant myeloma. PATIENT CHARACTERISTICS: * ECOG/WHO performance status 0-2 * ANC ≥ 1,000/mm³ * Platelet count ≥ 75,000/mm³ * Total bilirubin ≤ 2 times upper limit of normal (ULN) * AST and ALT ≤ 2 times ULN * Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 90 days after completion of study treatment * No blood, sperm, or ova donation during and for ≥ 4 weeks after completion of study treatment * Able to obtain commercially available lenalidomide via Celegene's RevAssist® program * Registered in the RevAssist® program * Willing and able to comply with the requirements of RevAssist® * Able to swallow capsules * No severe or uncontrolled systemic illness * No "currently active" second malignancy, other than nonmelanoma skin cancer or carcinoma in situ of the cervix * Patients are not considered to have a "currently active" malignancy if they completed therapy for the malignancy, are disease free from the malignancy for \> 5 years, and are considered by their physician to be at \< 30% risk of relapse * No congenital long QT syndrome * No drug or alcohol abuse within the past 12 months * No history of allergic reactions (including erythema nodosum) attributed to compounds of similar chemical or biologic composition to lenalidomide, thalidomide, or vorinostat * No other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the study results PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior class Ia, Ib, or Ic antiarrhythmic medication * No prior HDAC inhibitor-like compounds (e.g., valproic acid) as anticancer therapy * More than 30 days since prior HDAC inhibitor-like compounds for other indications (e.g., valproic acid for epilepsy) * No prior gastrointestinal surgery or other procedure that may, in the opinion of the investigator, interfere with the absorption or swallowing of the study drugs * No concurrent corticosteroids other than for physiologic maintenance treatment * No concurrent radiotherapy, unless for local control of bone pain * Irradiated area should be as small as possible * Lesions within the irradiated field cannot be used for response assessment * No concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and anticancer activity of the study drugs * No other concurrent anticancer therapy, including chemotherapy or biologic therapy * No other concurrent HDAC inhibitors (e.g., valproic acid)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Sborov DW, Benson DM, Williams N, Huang Y, Bowers MA, Humphries K, Efebera Y, Devine S, Hofmeister CC. Lenalidomide and vorinostat maintenance after autologous transplant in multiple myeloma. Br J Haematol. 2015 Oct;171(1):74-83. doi: 10.1111/bjh.13527. Epub 2015 Jun 8.

  PMID: 26058589 DERIVED

Related Links

• Jamesline

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Lenalidomide; Vorinostat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anilides; Amides; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids

Study Officials

• Yvonne C. Efebera, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 7, 2008
• Study Start: September 26, 2008
• Primary Completion: December 26, 2019
• Study Completion: May 4, 2020
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)