Lenalidomide Maintenance Therapy for Multiple Myeloma

NCT01675141 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 12019212-C-0192
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Multiple myeloma is rarely curable, but it is treatable. Initial treatment is directed at controlling symptoms and reducing the number of myeloma cells. It continues until the cancer stops responding to treatment. At that time, treatment may switch to maintenance therapy, which is given to try to extend the response of the first therapy for as long as possible. Research suggests that lenalidomide maintenance therapy may delay the time for myeloma cells to start to grow and possibly improve survival.
• Lenalidomide is a drug that may reduce or prevent the growth of cancer cells. Researchers want to look at the long-term effect of lenalidomide on immune cells. It will also look at the effects of extended treatment on the cancer and the immune system. Objectives: \- To test the long-term effectiveness of lenalidomide therapy for multiple myeloma. Eligibility: \- Individuals at least 18 years of age with newly diagnosed or relapsed multiple myeloma. Design:
• Participants will be screened with a physical exam and medical history. Blood and urine sample will be collected. A bone scan and bone marrow biopsy will also be performed.
• Participants will receive lenalidomide maintenance treatment. It will be given according to the standard of care for multiple myeloma. Participants will take lenalidomide every day for 21 days of repeated 28-day cycles.
• Treatment will be monitored with frequent blood tests. Blood tests will look at the effect of the treatment on the immune system.
• Treatment will continue as long as the cancer does not worsen and the side effects are not severe.

Conditions

Multiple Myeloma

Keywords

NK Cell Function; Immunomodulatory Drugs; T Cell Activity; Immune Stimulatory Effects; Extended Dosing

Outcome Measures

Primary Outcomes (1)

• Longitudinal Assessment of T Cell (Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Natural Killer T-cell (NKT) and Natural Killer (NK) Cell Counts

  Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry.

  participants were followed for the duration of their treatment, an average of 2 years

Secondary Outcomes (6)

• Number of Participants With Serious and Non-serious Adverse Events

  37 months and 12 days

• Duration of Response

  participants were followed for the duration of their treatment, an average of 2 years

• Progression Free Survival (PFS)

  participants were followed for the duration of their treatment, an average of 2 years

• Natural Killer (NK) Cell Function and Activity

  participants were followed for the duration of their treatment, an average of 2 years

• Changes in B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy

  participants were followed for the duration of their treatment, an average of 2 years

Study Arms (1)

Lenalidomide Maintenance Therapy for Multiple Myeloma

EXPERIMENTAL

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide Maintenance Therapy for Multiple Myeloma

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with multiple myeloma treated with induction therapy or re-induction therapy, who at the time of study enrollment have documented evidence of stable disease response or better according to International Myeloma Workshop Consensus Panel. The response assessment must occur at least 4 weeks after completion of their last treatment.
• Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of lenalidomide in patients
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
• Patient must have adequate hematologic, renal, hepatic, and cardiac function as defined by:
• Absolute neutrophil count greater than or equal to 1.0 K/microL independent of growth factor support
• Platelets greater than or equal to 75K/microL
• Hemoglobin greater than or equal to 8 g/dL (transfusions are permissible)
• Calculated creatinine (CrCl) clearance of greater than or equal to 40 mL/min. using the Cockcroft-Gault method. If the calculated CrCl based on Cockcroft-Gault method is
• Total bilirubin less than or equal to 1.5 mg/dL, aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) less than or equal to 3 times ULN
• Females of childbearing potential (FCBP) must agree to use two effective forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of effective contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal \[birth control pills, injections, or implants\], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
• A FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
• A FCBP must have two negative serum or urine pregnancy tests prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to prescribing the study drug. The prescriptions of study drug must be filled within 7 days.
• Male patients must agree to use a latex condom during sexual contact with FCBP while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
• Patient must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin.
• Patient must understand and voluntarily sign an informed consent form, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.

You may not qualify if:

• Patients with progressive or refractory multiple myeloma (MM), as defined by International Myeloma Workshop Consensus Panel criteria.
• Refractory to lenalidomide in the most recent line of therapy, as defined by the International Myeloma Consensus Panel criteria - as failure to achieve minimal response or development of progressive disease while on lenalidomide or within 30 days of lenalidomide therapy
• Patients who are receiving any other investigational agents with the intent to treat myeloma. Permitted concurrent therapies include:
• Bisphosphonates
• Radiotherapy to single stable disease site
• Plasma cell leukemia
• Pregnant or lactating females. Because there is a potential risk for adverse events to nursing infants secondary to treatment of the mother with lenalidomide, lactating females must agree not to breast feed while taking lenalidomide.
• Uncontrolled hypertension or diabetes
• Active hepatitis B or C infection
• Diagnosed or treated for another malignancy within 3 years prior to study enrollment, with the exception of complete resection of non-melanoma skin cancer, or an in situ malignancy
• Previous diagnosis of another malignancy with any evidence of residual disease.
• Patients seropositive for the human immunodeficiency virus (HIV), and/or those who are taking anti-retroviral treatment for HIV/acquired immune deficiency syndrome (AIDS)
• Prior organ transplant requiring immunosuppressive therapy
• Prior allogeneic stem cell transplant
• Patients requiring continuous, systemic immunosuppressive therapy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Celgene Corporation: collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med. 2004 Oct 28;351(18):1860-73. doi: 10.1056/NEJMra041875. No abstract available.

  PMID: 15509819 BACKGROUND

• Landgren O, Kyle RA, Pfeiffer RM, Katzmann JA, Caporaso NE, Hayes RB, Dispenzieri A, Kumar S, Clark RJ, Baris D, Hoover R, Rajkumar SV. Monoclonal gammopathy of undetermined significance (MGUS) consistently precedes multiple myeloma: a prospective study. Blood. 2009 May 28;113(22):5412-7. doi: 10.1182/blood-2008-12-194241. Epub 2009 Jan 29.

  PMID: 19179464 BACKGROUND

• Rajkumar SV, Kyle RA. Multiple myeloma: diagnosis and treatment. Mayo Clin Proc. 2005 Oct;80(10):1371-82. doi: 10.4065/80.10.1371.

  PMID: 16212152 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide

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

Results Point of Contact

• Title: Dr. Dickran Kazandijian
• Organization: National Cancer Institute

kazandijiandg@nih.gov

301-451-2677

Study Officials

• Dickran Kazandijicn, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2012
• First Posted: August 29, 2012
• Study Start: August 20, 2012
• Primary Completion: May 5, 2016
• Study Completion: March 10, 2017
• Last Updated: February 5, 2018
• Results First Posted: May 12, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)