NCT01355705 · REGISTRY CONDITION SEARCH

Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2018-09-18

To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria

→

outcome · POSTED

Duration of Response (DOR)

→

outcome · POSTED

Progression-free Survival (PFS)

→

outcome · POSTED

Time-to-next Treatment

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Relapsed or refractory multiple myeloma that has progressed following at least 1 prior therapy. * Measurable disease defined as one of the following: * Serum M-protein ≥ 1 g/dL * Urine M-protein ≥ 200 mg/24 hours * Received at least 1 prior line of systemic treatment that may have included lenalidomide and/or an anthracycline. * No cytotoxic chemotherapy within 4 weeks prior to first dose of amrubicin. This interval may be reduced to 14 days for thalidomide, lenalidomide, bortezomib or corticosteroids, provided other entry criteria are met. * Age ≥ 18 at the time of consent. * Life expectancy of more than ≥ 3 months. * No known central nervous system involvement by myeloma. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 at study registration during phase 1. Once safety is confirmed, ECOG performance status 0 to 2 at study registration during phase 2. * No poorly-controlled intercurrent illness. * Platelets \> 100 x 10\^9/L * Hemoglobin \> 8.0g/dL * Absolute neutrophil count (ANC) \>1.5 x 10\^9/L * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN) * Total bilirubin ≤ 1.5 x ULN * Calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula. * Left ventricular ejection fraction (LVEF) ≥ 50% by Echocardiogram (ECHO) or multiple gate acquisition scan (MUGA) * All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the Requirements of RevAssist. * Disease-free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 U/mL within 10 to 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days 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 a FCBP even if they have had a successful vasectomy. * Ability to understand and the willingness to sign a written informed consent document. * Able to adhere to the study visit schedule and other protocol requirements. * Able to take aspirin (81 or ≥ 25 mg) daily as prophylactic anticoagulation. Patients intolerant to aspirin may use warfarin or low molecular weight heparin (LMWH). Patients with previous thromboembolic event on lenalidomide or thalidomide may be started on warfarin or LMWH. Patients already taking warfarin or LMWH do not require additional aspirin.. * Lactating females must agree not to breast-feed while taking lenalidomide Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or breastfeeding females. * Any concurrent severe or uncontrolled medical disease 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 28 days of first dose of amrubicin. * Known hypersensitivity to thalidomide or lenalidomide. * The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. * LVEF ≤ 50%. * Concurrent use of other anti-cancer agents or treatments. * Known positive for HIV, or infectious hepatitis, type B or C. * Cranial radiotherapy ≤ 21 days prior to first dose of amrubicin; radiotherapy to all other areas ≤ 7 days prior to first dose of amrubicin.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles. Concurrent therapeutic medications: * Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14 * Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15) Other drugs: * Aspirin: 81 or 325 mg daily oral * Pegfilgrastim subcutaneous on Day 2
intervention Names
Drug: Amrubicin
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Aspirin
Drug: Pegfilgrastim
label
Amrubicin + Lenalidomide + Dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
Amrubicin + Lenalidomide + Dexamethasone
description
40, 60, or 80 mg/m2 intravenous (IV)
name
Amrubicin
other Names
SM-5887
type
DRUG
arm Group Labels
Amrubicin + Lenalidomide + Dexamethasone
description
15 mg daily by mouth
name
Lenalidomide
other Names
CC-5013
Revlimid
type
DRUG
arm Group Labels
Amrubicin + Lenalidomide + Dexamethasone
description
40 mg weekly by mouth
name
Dexamethasone
other Names
Decadron
Dexamethasone Intensol
Dexpak Taperpak
type
DRUG
arm Group Labels
Amrubicin + Lenalidomide + Dexamethasone
description
81 or 325 mg daily by mouth
name
Aspirin
other Names
acetylsalicylic acid
type
DRUG
arm Group Labels
Amrubicin + Lenalidomide + Dexamethasone
description
6 mg subcutaneous on Day 2
name
Pegfilgrastim
other Names
Neulasta
PEG-GCSF
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 14
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Modified International Myeloma Working Group Uniform Response Criteria: Complete (CR)= * Negative for monoclonal protein (MP) in urine (U) and serum (S) + * No tissue plasmacytomas (PC) + * \<5% plasma cells (PCs) in marrow (M) Stringent CR (sCR)= CR with normal light chain ratio+ no PCs in M Near CR (nCR)= CR, except MP persists in U and S Partial (PR)= S MP ≤50%, + U MP ≤90% or \<200 mg/24 hours (hr) Very Good PR (VGPR)= in S MP ≤90%, + U MP \<100 mg/24 hr Minimal (MR)= * S MP ≤51-75%, + * If light chain is excreted, reduced 50-89%/24 hr that is also \>200 mg/24 hr, + * No increase in lytic bone lesions Progressive disease (PD)= any of: * S MP ≥125% and/or ≥+0.5 g/dL, * U MP ≥125% and/or ≥+200 mg/24 hr * New or increased bone lesions/PC * S calcium \>11.5 mg/dL (attributed to increased PCs) PD after CR/sCR= * Reappearance of S or U MP * ≥5% clonal PCs in M * New PC, lytic bone lesions, hypercalcemia Stable Disease (SD)= Not CR, VGPR, MR, PR, or PD
measure
Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria
time Frame
12 weeks

secondary Outcomes

measure
Duration of Response (DOR)
time Frame
140 days
description
Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of: * Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline, * Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline * New or increased bone lesions or plasmacytomas * Serum calcium \> 11.5 mg/dL (attributed to increased plasma cells)
measure
Progression-free Survival (PFS)
time Frame
9 months
measure
Time-to-next Treatment
time Frame
9 months

Full study description

brief Summary: To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.
detailed Description: PRIMARY OBJECTIVES * Establish the maximum tolerated dose (MTD) and toxicity profile for the combination of amrubicin with lenalidomide and dexamethasone in previously treated adult patients with multiple myeloma during Phase I * Determine the combined rate of complete response (CR) and very good partial response (VGPR) for this combination in this population as defined by the International Myeloma Working Group Uniform Response Criteria (IMWGURC) SECONDARY OBJECTIVES * Determine the overall response rate (CR, VGPR and PR) * Assess additional evidence of ant-tumor activity as measured by duration of response (DOR), progression-free survival (PFS), time to tumor progression (TTP), and overall survival (OS)

Source references

references

citation
Dinner S, Dunn TJ, Price E, Coutre SE, Gotlib J, Berube C, Kaufman GP, Medeiros BC, Liedtke M. A phase I, open-label, dose-escalation study of amrubicin in combination with lenalidomide and weekly dexamethasone in previously treated adults with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Sep;108(3):267-273. doi: 10.1007/s12185-018-2468-5. Epub 2018 May 25.
pmid
29802551
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-4e47db4dc584cea25838
requested nct id
NCT01355705
primary nct id
NCT01355705
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
844ae6a41edef9a6e0dcd2a36b27b4bba3bfbc3f1a4a4fc0914d182fca8d76dc
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-4e47db4dc584cea25838
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT01355705
occurrences
context exact
NCT01355705
end
11
exact text
NCT01355705
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/134/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
f9f52ae769dc01fede92dddbb93484ee6dda49a12e1aeaf4607909e4811c82c9
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice