Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma

NCT01159574 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1004011012PO-MM-PI-0023
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to investigate the combination of the combination of dexamethasone (Decadron®), Clarithromycin (Biaxin®), and pomalidomide (CC-4047®) \[ClaPd\] in multiple myeloma patients who have relapsed or refractory disease who have failed prior treatment with lenalidomide when used alone or in combination with corticosteroids. Primary endpoint will be response rate to treatment. Secondary endpoints will include toxicity of the combination, time to maximum response, and time to disease progression

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Best response rate was recorded for all patients, using the IMWG criteria.

  from baseline to cycle with maximum response, which was achieved on average after 2 cycles

Secondary Outcomes (2)

• Time to Maximum Response, Expressed as Number of Cycles of Treatment to Maximum Response

  From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days

• Time to Disease Progression (Progression Free Survival)

  From start of treatment, to date of disease progression

Study Arms (1)

all patients

EXPERIMENTAL

ClaPd therapy: Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle. Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.

Drug: dexamethasone; Drug: clarithromycin; Drug: Pomalidomide

Interventions

dexamethasone DRUG

40mg will be given on days 1, 8, 15, 22 of a 28-day cycle

Also known as: Decadron

all patients

clarithromycin DRUG

orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle

Also known as: Biaxin

all patients

Pomalidomide DRUG

orally 4mg daily for days 1-21 of each 28 day cycle

Also known as: CC-4047

all patients

Eligibility Criteria

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

You may qualify if:

• Subject must voluntarily sign and understand written informed consent.
• Age \> 18 years at the time of signing the consent form.
• Histologically confirmed MM
• Relapsed or refractory myeloma, progression of disease either after prior therapy or lack of response to currently used therapy.
• Relapsed or progressive disease after at least 3 prior therapeutic treatments or regimens for multiple myeloma.
• Must have been previously treated with lenalidomide and has been determined to be refractory, resistant, or relapsed.
• Measurable disease as defined by \> 0.5 g/dL serum monoclonal protein, \>0.1 g/dL serum free light chains, \>0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
• Karnofsky performance status ≥70% (\>60% if due to bony involvement of myeloma
• Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and thalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy. See Appendix V: Pomalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. †A female of childbearing potential is 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).
• Able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). †
• ife expectancy ≥ 3 months
• Subjects must meet the following laboratory parameters:
• Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Platelets count ≥ 50,000/mm3 (75 x 109/L) Serum SGOT/AST ≤ 2.0 x upper limits of normal Serum SGPT/ALT \<3.0 x upper limits of normal (ULN) Serum creatinine ≤ 2.5 x upper limits of normal Serum total bilirubin ≤ 1.5 x upper limits of normal

You may not qualify if:

• Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine).
• Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 5 years.
• Myocardial infarction within 6 months prior to enrollment, or NYHA(New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• Known HIV infection
• Known hepatitis B or hepatitis C infection.
• Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
• Any coexisting medical problem or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial.
• Known hypersensitivity to thalidomide or lenalidomide.
• History of thromboembolic event within the past 6 months prior to enrollment.
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females.
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 14 days of baseline.
• Known hypersensitivity to thalidomide or lenalidomide.
• The development of erythema nodorum if characterized by a desquamating rash while taking thalidomide, CC-4047 or similar drugs.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Celgene: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (1)

• Mark TM, Forsberg PA, Rossi AC, Pearse RN, Pekle KA, Perry A, Boyer A, Tegnestam L, Jayabalan D, Coleman M, Niesvizky R. Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. Blood Adv. 2019 Feb 26;3(4):603-611. doi: 10.1182/bloodadvances.2018028027.

  PMID: 30792190 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone; Calcium Dobesilate; Clarithromycin; pomalidomide

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Results Point of Contact

• Title: Jennifer Hess
• Organization: Weill Cornell Medical College

jmh2004@med.cornell.edu

6469629440

Study Officials

• Ruben Niesvizky, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: July 9, 2010
• Study Start: August 1, 2010
• Primary Completion: May 5, 2015
• Study Completion: May 5, 2015
• Last Updated: June 11, 2019
• Results First Posted: April 12, 2017

Record last verified: 2019-05

Locations

US (1)