Efficacy of NF-kB Inhibition for Reducing Symptoms During Maintenance Therapy in Multiple Myeloma Patients

NCT01269203 | Withdrawn Phase 2 DMC

• 1 other identifier: 2010-0457
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical research study is to learn if curcumin can reduce the symptoms reported by patients with multiple myeloma (MM) who receive treatment with lenalidomide.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; MM; maintenance therapy; lenalidomide; bone marrow transplantation; auto-HSCT; Autologous Hematopoietic Stem Cell Transplantation; NF-kB inhibition; reducing symptoms; maintenance chemotherapy; inflammatory cytokines; nuclear factor kappa B; NF-kB; interleukin; IL-6; tumor necrosis factor; TNF-a; NF-kB activation levels

Outcome Measures

Primary Outcomes (1)

• AUC from 3 months Post-Transplantation to 9 months Post-Transplantation

  Daily area under the curve (AUC) where AUC is based on average of 5 most severe symptoms (pain, fatigue, bone aches, numbness, disturbed sleep) being experienced by MM patients as measured by MDASI-MM, a multiple-symptom measure of cancer-related symptoms rate severity of physical, affective, and cognitive symptoms on 0-10 numeric scales, ranging from 0 "not present" to 10 "as bad as you can imagine."

  Assessments within +/-3 days of 4 week cycle start date for 6 cycles.

Study Arms (2)

Curcumin

ACTIVE COMPARATOR

1000 mg/day Curcumin + 5 -15 mg/day Lenalidomide

Drug: Curcumin

Placebo

PLACEBO COMPARATOR

Placebo daily + 5 -15 mg/day Lenalidomide

Other: Placebo

Interventions

Curcumin DRUG

1000 mg per day

Curcumin

Placebo OTHER

Administered daily same as Curcumin.

Placebo

Eligibility Criteria

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

You may qualify if:

• Must have a histologically confirmed diagnosis of multiple myeloma.
• Must be \>/= 18 years of age.
• Must have a performance status (ECOG PS) of 0-2.
• Must be qualified and have signed consent to receive lenalidomide for maintenance therapy for MM.
• Must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.
• Must also agree to refrain from use of self prescribed curcumin during the course of the study.
• Must have negative pregnancy test before signing consent for MM therapy.

You may not qualify if:

• Unable to understand the symptom assessment or not willing to participate in the study.
• Treatment for other carcinomas within the last 5 years, except for cured non-melanoma skin and treated in-situ cervical cancer.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or requiring IV antibiotics, cardiac disease (NYHA class III or IV heart failure), unstable angina pectoris, unstable cardiac arrhythmia or tachycardia, or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.
• Concurrent use of coumadin other than low dose (1 mg) coumadin used for line patency.
• Concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium hydroxide-containing antacids such as Maalox.
• Sorivudine and brivudine use within 4 weeks of the start of study treatment.
• Gastric or duodenal ulcers, or gastric hyperacidity disorders.
• Currently receiving anticoagulants (heparin) or antiplatelets (clopidogrel, ticlopidine, aspirin/dipyridamole)
• INR \> 1.5 (upper limit of normal = 1.5).
• History of deep vein thrombosis.
• Received allogeneic transplant.
• Allergy to turmeric, Curcumin, or yellow dye.
• Bowel or bile duct obstruction.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Curcumin

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)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Robert Orlowski, MD, PhD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: January 4, 2011
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Last Updated: September 7, 2012

Record last verified: 2012-09