ACVDL Treatment for Patients With Newly Diagnosed Multiple Myeloma

NCT01481194 | Completed Phase 2 DMC

• 1 other identifier: SDU/VS-HKU/CTC-2011-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of the combination treatment of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide in newly diagnosed multiple myeloma patients.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Response rate

  4 weeks after completion of 8 treatment cycles

Secondary Outcomes (4)

• Complete response rate

  4 weeks after completion of 8 treatment cycles

• Very good partial response rate

  4 weeks after completion of 8 treatment cycles

• Time to progression

  4 years

• Progression free survival

  4 years

Study Arms (1)

ACVDL

EXPERIMENTAL

ACVDL is a combination of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide

Drug: Doxorubicin; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Cyclophosphamide

Interventions

Doxorubicin DRUG

50 mg/m2 IV on day 1 of a 21-day cycle

ACVDL

Bortezomib DRUG

1.3 mg/m2 IV push on days 2 and 9 of a 21-day cycle

ACVDL

Lenalidomide DRUG

15 mg orally on days 1-14 of a 21-day cycle

ACVDL

Dexamethasone DRUG

20 mg orally on days 2, 3, 9, and 10 of a 21-day cycle

ACVDL

Cyclophosphamide DRUG

750 mg/m2 IV on day 1 of a 21-day cycle

ACVDL

Eligibility Criteria

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

You may qualify if:

• Male or female subjects ≥ 18 years at the time of signing informed consent.
• Subject is diagnosed with symptomatic multiple myeloma based on the International Myeloma Working Group Diagnostic Criteria (Kyle 2009):
• Monoclonal plasma cells in the bone marrow ≥ 10% and/or presence of a biopsy-proven plasmacytoma.
• Monoclonal protein present in the serum and/or urine. If no monoclonal protein is detected (non-secretory disease), then ≥ 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma is required.
• Myeloma-related organ dysfunction
• The myeloma disease burden must be measurable with at least one of the following criteria (Durie et al. 2006):
• Serum M-protein ≥ 10 g/l
• Urine M-protein ≥ 200 mg/24 h
• Involved FLC ≥ 100 mg/l provided serum FLC ratio is abnormal
• Bone marrow plasma cells \> 30%
• Subject has a Karnofsky performance status of ≥ 60.
• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Subject is willing and able to comply with the protocol as judged by the investigator.

You may not qualify if:

• Any prior systemic therapy for multiple myeloma.
• Other therapies such as biologic therapy and chemotherapy less than 3 months prior to screening.
• Any prior treatment with doxorubicin or other anthracycline.
• Concurrent or recent (less than 2 weeks prior to Screening) radiotherapy or surgery.
• Prior glucocorticoid treatment of multiple myeloma exceeding dexamethasone 20mg/day for a maximum of 7 days. Topical glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
• More than or equal to grade 2 peripheral neuropathy according to the NCI-CTC criteria on clinical examination within 14 days before enrolment (Day 1 of Cycle 1).
• Evidence of mucosal or internal bleeding and/or platelet counts \< 50 x 10\^9/l. Platelet transfusions may not be used to meet PLT eligibility criteria.
• Absolute neutrophil count (ANC) \< 1 x 10\^9/l. Growth factors may not be used to meet ANC eligibility criteria.
• Hemoglobin \< 5.0 mmol/l. The subject may be included after correction of the hemoglobin level by transfusion or treatment with erythropoietin.
• Alanine aminotransferase (ALAT) \> 2 x ULN.
• Myocardial infarction within 6 months prior to enrolment or New York Heart Association (NYHA) Class IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
• Clinically relevant active infection or serious co-morbid medical conditions, such as chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis.
• Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study.
• Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer for which the subject has been disease-free for at least 3 years.
• Female subject is pregnant or breast-feeding. The first serum pregnancy test to be done within 10-14 days prior to the study treatment start and repeated serum pregnancy test to be done within 24 hours prior to the start of study treatment.

Sponsors & Collaborators

• Vejle Hospital: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Department of Hematology

Vejle, Denmark

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Doxorubicin; Bortezomib; Lenalidomide; Dexamethasone; Cyclophosphamide

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)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Torben Plesner, DMSc

  Vejle Hospital

  STUDY CHAIR

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: November 21, 2011
• First Posted: November 29, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: August 28, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

DK (1)