Lenalidomide/Low-dose Dexamethasone in Combination With Continuous Oral Cyclophosphamide Compared to Lenalidomide/Low-dose Dexamethasone Combined With Single Cyclophosphamide Doses IV in Patients With Relapsed/Refractory Multiple Myeloma

NCT01019174 | Completed Phase 1 DMC

• 2 other identifiers: RV-MM-DSMM-0279GMIHO-005/2008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to investigate the efficacy and tolerability of LEN/low-dose DEX and continuous low-dose CY administered orally compared to LEN in combination with low-dose DEX and single CY doses IV in patients with relapsed MM.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• To determine the maximum tolerated dose (MTD) of CY (PO and IV) in combination with LEN/low-dose DEX

  3 years

• To investigate the best objective response (EBMT criteria) to both treatment regimens

  3 years

Secondary Outcomes (2)

• To investigate safety and tolerability of both treatment regimens

  3 years

• To investigate other efficacy parameters of both treatment regimens

  3 years

Study Arms (2)

oral application

ACTIVE COMPARATOR

oral application Cyclophosphamide

Drug: Cyclophosphamide

intravenous application

ACTIVE COMPARATOR

intravenous application Cyclophosphamide

Drug: Cyclophosphamide

Interventions

Cyclophosphamide DRUG

comparison of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses intravenous

Also known as: Revlimid, Endoxan

oral application

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Age at least 18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Previously diagnosed with multiple myeloma based on standard criteria and requires therapy for primary refractory disease or 1st - 3rd relapse because of progressive disease (PD), defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytoma, or hypercalcemia (serum calcium \> 11.3 mg/dL), or clinical relapse from CR.
• At least one measurable disease manifestation defined as follows:
• For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, \> 1g/dL IgG M-protein or \> 0.5 g/dL IgA) and, where applicable, urine light-chain excretion of ≥ 200 mg/24 h.
• For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or a quantifiable plasma cell infiltration of the bone marrow as determined by bone marrow biopsy.
• ECOG performance status equal to or less than 2 at time of randomization/registration (see Appendix I).
• Laboratory test results within these ranges within 1 week prior to randomization/registration:
• Absolute neutrophil count ≥ 1.5 x 109/L without the use of colony stimulating factors within 14 days before the laboratory test.
• Platelet count ≥ 75 x 109/L without transfusion support within 14 days before the laboratory test.
• Hemoglobin ≥ 7.5 g/dL (regardless of transfusion support or prior medication with erythropoietin).
• Calculated creatinine clearance ≥ 50 mL/minute.
• Total bilirubin equal to or less than 1.5 mg/dL.
• AST (SGOT) and ALT (SGPT) equal to or less than 2,5 x ULN.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Females, who are pregnant, calculate to get pregnant or are breast feeding (Lactating females must agree not to breast feed while taking lenalidomide).
• Any condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Patient currently is enrolled in another clinical research study or has been enrolled in such a study within 4 weeks before randomization/registration and/or is receiving an investigational agent for any reason or has received such an agent within 4 weeks before randomization/registration.
• Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide or similar drugs.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or infectious hepatitis, type A, B or C.
• Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.
• Immunotherapy or antibody therapy within 8 weeks before randomization/registration.
• Major surgery within 4 weeks before randomization/registration.
• Myocardial infarction within 6 months before randomization/registration, New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• Cardiac amyloidosis.
• Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.
• Any systemic infection requiring treatment.

Sponsors & Collaborators

• Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH: lead

Study Sites (4)

University Clinic München-Großhadern

München, 81377, Germany

Location

University of Münster, Department of Hematology/Oncology

Münster, 48129, Germany

Location

Tübingen University, Department of Hematology/Oncology/Immunology

Tübingen, 72076, Germany

Location

University Clinic Ulm, Department Internal Medicine

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Cyclophosphamide; 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)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Martin Kropff, MD

  University of Münster, Department of Hematology/Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 20, 2017

Record last verified: 2014-07

Locations

DE (4)