Study of Pomalidomide, Cyclophosphamide, Dexamethasone in Relapsed/Refractory Multiple Myeloma

NCT02176213 | Completed Phase 2 DMC

• 2 other identifiers: GCO 14-0825PO-CL-MM-PI-002404
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to learn more about the drug, pomalidomide and to gather data on its safety and side effects when used in combination with commercially available cyclophosphamide and dexamethasone. This combination is considered experimental and has not been approved by the FDA. Pomalidomide is a third generation immunomodulatory (IMiDs) agent, which is a more potent version of thalidomide and lenalidomide drugs that have been approved by the United States Food and Drug Administration \[FDA\] for the treatment of MM. In February 2013, pomalidomide was also approved by the FDA for patients with MM who have had more than 2 types of therapy. Pomalidomide is taken orally as capsules, and cyclophosphamide and dexamethasone are also taken orally as tablets in this study. Cyclophosphamide and dexamethasone are commercially available and are often used in combination with other drugs to treat Multiple Myeloma. Preliminary data from both the laboratory and patient studies suggest that this combination of drugs is more effective than pomalidomide and dexamethasone alone. However, the regimen being used in this study, which consists of daily cyclophosphamide, also permits support of low blood counts with either injections or transfusions as needed.

Conditions

Multiple Myeloma in Relapse; Multiple Myeloma, Refractory

Keywords

Relapsed; Refractory; Multiple Myeloma; Pomalidomide; Cyclophosphamide; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Best overall response rate (ORR)

  disease response

  up to 24 months

Secondary Outcomes (9)

• Stringent complete response (sCR)

  up to 24 months

• Complete response (CR)

  up to 24 months

• Very good partial response (VGPR)

  up to 24 months

• Partial response (PR)

  up to 24 months

• Time to progression (TTP)

  up to 24 months

Study Arms (1)

Pomalidomide, Cyclophosphamide, Dexamethasone

EXPERIMENTAL

Three oral drugs will be given in 28-day cycles: Pomalidomide 4 mg daily x 21 days; cyclophosphamide 50 mg BID x 21 days; and dexamethasone 40 mg weekly x 3 (20 mg weekly if the patient aged ≥ 75 years old)

Drug: Pomalidomide; Drug: Cyclophosphamide; Drug: Dexamethasone

Interventions

Pomalidomide DRUG

4 mg PO x 21 days

Also known as: pomalyst

Pomalidomide, Cyclophosphamide, Dexamethasone

Cyclophosphamide DRUG

low dose cyclophosphamide 50 mg PO BID x 21 days

Also known as: cytoxan

Pomalidomide, Cyclophosphamide, Dexamethasone

Dexamethasone DRUG

dexamethasone 40 mg PO weekly (or 20 mg if ≥ 75 years old).

Pomalidomide, Cyclophosphamide, Dexamethasone

Eligibility Criteria

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

You may qualify if:

• Disease related:
• Patients must have a history of symptomatic multiple myeloma according to the IMWG criteria
• Patients must have received at least two prior lines of therapy and also must be refractory to lenalidomide.
• Patient has relapsed or relapsed/refractory MM.
• Patients must currently have measurable disease, as defined as:
• Serum M-protein ≥ 0.5 g/dL
• Urine M-protein ≥ 200 mg/24 hours
• Serum free light chain assay: involved FLC level ≥ 10 mg/dl provided serum FLC ratio is abnormal
• If no monoclonal protein is detected, then \> 30% monoclonal bone marrow plasma cells
• Demographic:
• Male or female adults ≥ 18 years old
• Able to sign informed consent and to comply with the protocol
• Life expectancy \> 12 weeks
• ECOG performance status ≤ 2
• All study participants must be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program.

You may not qualify if:

• Previous treatment with pomalidomide
• Patients who received chemotherapy or radiation therapy to 30% of marrow-bearing bone within ≤ 2 weeks or experimental agent/therapy within 4 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
• Known hypersensitivity to thalidomide or lenalidomide
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or similar drugs
• Other concurrent severe and/or uncontrolled medical conditions including abnormal laboratory values that could cause unacceptable safety risks or compromise compliance with the protocol
• Patients for whom prophylactic anticoagulation therapy is not an option unless due to thrombocytopenia
• Patients who received allogenic stem cell transplantation \< 12 months prior to entering the study or show evidence of active graft-versus-host disease that requires immunosuppressive therapy
• Patients with existing peripheral neuropathy grade \> 2
• Patients with an active malignancy requiring treatment in the next 12 months (except for basal or squamous cell carcinoma, or in situ cancer of the cervix or breast, and asymptomatic prostate cancer)
• Patients with known positivity for HIV or active hepatitis B or C
• Corticosteroid therapies of \> 20 mg/day prednisone, \> 4 mg/day dexamethasone, \> 80 mg/day hydrocortisone, or equivalent. Oral, inhaled, or topical steroids are allowed during study as long as it does not exceed 80 mg/day hydrocortisone.

Sponsors & Collaborators

• Ajai Chari: lead
• Celgene Corporation: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

pomalidomide; Cyclophosphamide; Dexamethasone

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ajai Chari, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

US (1)