Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma

NCT00724568 | Completed Phase 1 Results DMC

• 2 other identifiers: UMCC 2007.098HUM 12962
• Study Type: interventional
• Target: 74
• Locations: 2 countries
• Sites: 6

Brief Summary

This research study is evaluating an investigational combination of four drugs called Revlimid® (lenalidomide), Velcade® (bortezomib), Dexamethasone and Doxil® (RVDD) as a possible treatment for newly diagnosed multiple myeloma.

Conditions

Multiple Myeloma

Keywords

Newly Diagnosed Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)

  Dose Level 1: 15 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 20 mg/m2 Doxil daily on day 4 Dose Level 2: 20 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 20 mg/m2 Doxil daily on day 4 Dose Level 3: 25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 20 mg/m2 Doxil daily on day 4 Dose Level 4: 25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12\* and 30 mg/m2 Doxil daily on day 4

  1 month post treatment

Secondary Outcomes (1)

• The Percentage of Patients That Achieved Partial or Complete Response to Treatment.

  24 weeks (8, 21-day cycles)

Study Arms (1)

Combination Drug Therapy

EXPERIMENTAL

Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles. To determine the MTD of the combination of Revlimid, Velcade, dexamethasone, and Doxil, four dose levels are planned.

Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Doxil

Interventions

Lenalidomide DRUG

Patients will be treated with Revlimid on days 1-14 in 3-week cycles for 4-8 cycles.

Also known as: Revlimid

Combination Drug Therapy

Bortezomib DRUG

Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11

Also known as: Velcade

Combination Drug Therapy

Dexamethasone DRUG

Patients will be treated with Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels.

Combination Drug Therapy

Doxil DRUG

Patients will be treated with Doxil on day 4.

Combination Drug Therapy

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age at the time of consent
• Measurable disease
• All necessary baseline studies completed
• LVEF (left ventricular ejection fraction) greater than or equal to 50 percent by MUGA (multigated acquisition scan) or ECHO (echocardiogram)
• Must be able to adhere to study visit schedule

You may not qualify if:

• Greater than or equal to grade 2 peripheral neuropathy on clinical examination within 14 days of enrollment
• Renal insufficiency
• Evidence of mucosal or internal bleeding and/ or platelet refractory.
• Absolute neutrophil count less than 1000 cells/mm\^2 within 14 days of enrollment.
• Acceptable labs
• Concomitant medications that include corticosteroids
• Myocardial infarction within 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias
• Clinically relevant active infection or serious medical condition that places the subject at unacceptable risk
• Any condition, including laboratory values that places the subject at an unacceptable risk
• Another malignancy within 3 years of enrollment, with the exception of the complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
• Hypersensitivity to bortezomib, boron, or mannitol or any of the components of DOXIL
• Female subject that is pregnant or breastfeeding.
• Can not have received any other investigational drugs within 14 days of enrollment
• Serious medical or psychiatric illness
• Uncontrolled diabetes mellitus

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (6)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Dana Farber Cancer Institute (and Massachusetts General)

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Jakubowiak AJ, Griffith KA, Reece DE, Hofmeister CC, Lonial S, Zimmerman TM, Campagnaro EL, Schlossman RL, Laubach JP, Raje NS, Anderson T, Mietzel MA, Harvey CK, Wear SM, Barrickman JC, Tendler CL, Esseltine DL, Kelley SL, Kaminski MS, Anderson KC, Richardson PG. Lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone in newly diagnosed multiple myeloma: a phase 1/2 Multiple Myeloma Research Consortium trial. Blood. 2011 Jul 21;118(3):535-43. doi: 10.1182/blood-2011-02-334755. Epub 2011 May 19.

  PMID: 21596852 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Bortezomib; Dexamethasone; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Moshe Talpaz
• Organization: University of Michigan Comprehensive Cancer Center

mtalpaz@umich.edu

734-764-8195

Study Officials

• Moshe Talpaz, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: July 29, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: September 3, 2014
• Last Updated: June 2, 2017
• Results First Posted: September 10, 2014

Record last verified: 2017-05

Locations

US (5); CA (1)