Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma

NCT01793051 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2012-0413P01CA124787NCI-2013-00700
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if minocycline can help reduce the symptoms reported by patients with MM who receive therapy with lenalidomide. Minocycline is an antibiotic and has been shown to interrupt pro-inflammatory cytokine production, which may help to reduce multiple symptoms.

Conditions

Myeloma

Keywords

Myeloma; Multiple Myeloma; MM; Symptom Burden; Symptom reduction; Maintenance therapy with lenalidomide; Minocycline; Dynacin; Minocin; Minocin PAC; Myrac; Solodyn; Placebo; Sugar pill; MD Anderson Symptom Inventory; MDASI; Questionnaires; Surveys

Outcome Measures

Primary Outcomes (1)

• Symptom Reduction

  Minocycline tested for its ability to reduce the value of a patient's 3 month (± two days) area under the curve (AUC) for the mean of 5 symptoms: fatigue, pain, muscle weakness, numbness, and bone aches. The AUC is calculated using a trapezoidal approximation, derived by multiplying half of the base with the sum of the two heights. The two heights correspond to the two mean symptom scores computed at each of these assessments. The AUC is measured in units of mean MDASI score in days. The area for the subsequent trapezoid can be calculated in the same way. Given a baseline, weekly assessment schedule over a three month period and end of trial assessment, there will be a total of 14 trapezoids. The AUC is the sum of the area of the 14 trapezoids. Each of the trapezoid has a maximum value of 70 (0.5\*7 days\*(10+10)). Hence, the AUC will have a minimum score of 0 and a maximum score of 980. Higher AUC values indicate worse outcomes.

  Baseline to 3 months (three cycles with assessments made at beginning of each)

Study Arms (2)

Minocycline

EXPERIMENTAL

Minocycline 200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for three months beginning at initiation of Lenalidomide maintenance chemotherapy for MM. Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.

Drug: Minocycline; Behavioral: Questionnaires

Placebo

PLACEBO COMPARATOR

Placebo 200 mg by mouth for the first day of Lenalidomide maintenance therapy for MM, then 100 mg doses every 12 hours for three months (three cycles of maintenance chemotherapy). Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.

Other: Placebo; Behavioral: Questionnaires

Interventions

Minocycline DRUG

200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for three months beginning at initiation of Lenalidomide maintenance therapy for MM.

Also known as: Dynacin, Minocin, Minocin PAC, Myrac, Solodyn

Minocycline

Placebo OTHER

200 mg by mouth for the first day of Lenalidomide maintenance therapy for MM, then 100 mg doses every 12 hours for three months (three cycles of maintenance chemotherapy).

Also known as: Sugar pill

Placebo

Questionnaires BEHAVIORAL

Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.

Also known as: Surveys, MD Anderson Symptom Inventory, MDASI

Minocycline; Placebo

Eligibility Criteria

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

You may qualify if:

• Patients with pathologically diagnosed who have received induction chemotherapy, with or without AuSCT, and who have qualified to receive lenalidomide-based maintenance therapy for their MM.
• Patients \> or = 18 years old.
• Patients able to render informed consent and to follow protocol requirements.
• Patients who speak English (due to patient-reported outcome language options, we are only accruing English-speaking patients to the protocol).
• Patients with normal renal function according to MD Anderson testing standards and no prior renal disease \[screening cut off for serum creatinine \< 1.5 times the upper limit of normal\].
• Patients with normal hepatic function according to MD Anderson testing standards and no prior liver disease \[screening results for total bilirubin must be \< 1.5 times the upper limit of normal; screening results for alkaline phosphatase (ALP) and alanine aminotransferase (ALT) must be \< 2 times the upper limit of normal; if available, screening results for aspartate aminotransferase (AST) must be \< 2 times the upper limit of normal\].

You may not qualify if:

• Patients who are taking minocycline for other conditions, as determined by the treating physician
• Patients with hypersensitivity to tetracyclines
• Women who are pregnant or nursing; pregnancy will be confirmed by urine test
• Patients who are enrolled in other clinical trials that have symptom management as primary outcome
• Patients who are not able to use telephone-based interactive voice response software due to physical limitations (e.g., impaired hearing)
• Patients taking any tetracycline in the last 15 days
• Patients on Vitamin K antagonist warfarin

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Multiple Myeloma; cyclopia sequence

Interventions

Minocycline; Sugars; Surveys and Questionnaires

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)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbohydrates; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Robert Orlowski, Professor, Lymphoma-Myeloma
• Organization: UT MD Anderson Cancer Center

rorlowski@mdanderson.org

(713) 794-3234

Study Officials

• Robert Orlowski, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: March 22, 2013
• Primary Completion: September 18, 2020
• Study Completion: September 18, 2020
• Last Updated: November 24, 2021
• Results First Posted: November 24, 2021

Record last verified: 2021-11

Locations

US (1)